DENTSPLY Dispersalloy, Инструкция по применению

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Dispersalloy
®
Directions for Use English
High Definition Micro Matrix Restorative
Caution: For dental use only.
In the USA: Rx only.
A dispersed phase admix amalgam, containing lathe-cut particles and silver/copper eutectic spheres.
1. COMPOSITION
Alloy Powder 1 spill 2 spill 3 spill Weight %
Silver 265 mg 393 mg 528 mg 69%
Tin 69 mg 103 mg 138 mg 18%
Copper 46 mg 69 mg 92 mg 12%
Zinc 4 mg 6 mg 8 mg 1%
Mercury 400 mg 588 mg 782 mg
The recommended alloy to mercury ratio by mass is approximately 1:1.
2. INDICATION FOR USE
Dispersalloy
®
Amalgam is designed for use in stress bearing restorations (Class 1 and 2), when other restorative
materials or restoration techniques are not indicated.
3. CONTRAINDICATION
The use of amalgam is contraindicated in patients with known allergies to amalgams or any of the components.
4. WARNINGS
1. It has been suggested by the Ad-hoc working group established by the European Commission that the
following information, be kept in mind when considering the use of dental amalgams:
• After placement or removal of dental amalgam restorations increased mercury concentration in blood and
urine has been observed. According to available scientific knowledge this increase has not been associated
with any adverse health effects.
• If placed in close contact with other metal restorations galvanic effects may occur. In most cases they will be of
short lasting duration. If the effect persists the user should consider replacement of the dental amalgam filling with
another material.
• There are no proven adverse effects on the fetus associated with the placement or presence of dental amalgam
fillings in the mother. It is sensible, however, where clinically feasible, to minimize health interventions during
pregnancy and avoid any unnecessary chemical exposure of the fetus. This precaution should be observed with
the use of all dental materials.
• It has also been recommended by certain regulatory authorities that consideration be given to the use of amalgam
fillings in children and that amalgams not be used in patients with severe renal disease.
2. Health Canada Warnings:
• Non-mercury filling materials should be considered for restoring the primary teeth of children where the
mechanical properties of the material are suitable.
• Whenever possible, amalgam fillings should not be placed in or removed from the teeth of pregnant women.
• Amalgam should not be placed in patients with impaired kidney function.
• In placing and removing amalgam fillings, dentists should use techniques and equipment to minimize the
exposure of the patient and the dentist to mercury vapor and to prevent amalgam waste from being flushed into
municipal sewage systems.
• Dentists should advise individuals who may have allergic hypersensitivity to mercury to avoid the use of
amalgam. In patients who have developed hypersensitivity to amalgam, existing amalgam restorations should be
replaced with another material where this is recommended by a physician.
3. Alloy amalgam capsule products contain mercury, which can cause skin sensitization or other allergic reaction.
Although the mercury in this product is bound within the amalgam following trituration, proper care should be taken
to prevent exposure to mercury.
Skin Contact: Before using this product wear protective safety glasses, clothing and gloves. If contact with skin
occurs immediately wipe off and flush with generous amounts of water, then wash well with soap and water after
contact. If skin rash, irritation, sensitization or other allergic reaction occurs, discontinue use and seek medical
attention immediately.
Eye Contact: May be irritating to eyes. Before using this product wear protective glasses as well as covering the
patient’s eyes to protect from excess. The use of an enclosed amalgamator is recommended. In case of accidental
contact with eyes, rinse eyes immediately with plenty of water and seek medical attention.
Ingestion:
Do not swallow or take internally. Whenever possible, the use of protective
barriers such as rubber dam isolation and protective mask during placement and removal is recommended. If
accidental swallowing occurs, drink lots of water. If nausea or illness develop, seek medical attention immediately.
Contact regional Poison Control Center immediately.
Inhalation: Do not breathe vapor. Whenever possible, the use of protective barriers such as rubber dam isolation,
high-volume evacuation and protective mask during placement and removal is recommended. Give oxygen or
artificial respiration if necessary.
4. Do not open capsule prior to trituration. Do not remove or handle mixing pestle or plastic wafer containing mercury.
5. Do not attempt to clean and/or reuse capsules.
6. THIS ALLOY CONTAINS ZINC; AMALGAM MADE THEREFROM MAY SHOW EXCESSIVE EXPANSION IF
MOISTURE IS INTRODUCED DURING MIXING AND CONDENSING.
5. PRECAUTIONS
1. This product is intended to be used only as specifically outlined in the Directions for Use. Any use of this product
inconsistent with the Directions for Use is at the discretion and sole responsibility of the practitioner.
2. Wear suitable protective eyewear, clothing, mask and gloves. Protective eyewear, and whenever possible, barrier
techniques such as rubber dam is recommended for patients. (See Warnings)
3. Mercury corrodes and embrittles particular metals and their alloys. Avoid unnecessary contact between mercury
and metals.
4. Mercury presents a health hazard if incorrectly handled. Mercury is toxic by vapor inhalation and the effect is
cumulative. Spillages of mercury should be removed immediately, including places which are difficult to access. Use
a plastic syringe to draw it up. Smaller quantities can be covered by sulfur powder and removed. Avoid inhalation of
the vapor.
5. Regulations for disposal must be observed. Adherence to the American Dental Association’s current “Best
Management Practices For Amalgam Waste (BMPs)” and “Dental Mercury Hygiene Recommendations” is strongly
recommended. Among these practices:
• Salvage and store non-contact amalgam scrap in well-sealed containers and recycle.
• Salvage and store contact amalgam pieces from restorations, traps and filters in well-sealed containers and
recycle.
• Do not dispose of amalgam scrap, waste or extracted teeth in regulated infectious waste containers that will be
incinerated, or in regular garbage.
• Recycle used disposable amalgam capsules and plastic wafer (which contained mercury before mixing).
6. Waste material and all primary containers that hold mercury must be disposed of as hazardous waste.
7. DISPERSALLOY
®
AMALGAM CONTAINS ZINC; If moisture is introduced into the amalgam before it has set,
properties such as strength and corrosion resistance may be affected adversely. If the alloy contains zinc, such
contamination may result in an excessive expansion (delayed expansion). Whenever it is possible, use a dry field.
8. Manufacturer’s variation in amalgamators and differences in local electrical current may necessitate adjusting
trituration time to obtain an optimal mix.
9. Insufficient data exist to support the use of amalgamators not listed in the chart below. Use of amalgamators other
than those listed may result in less than optimally triturated amalgam. The operator must investigate non-listed
equipment compatibility and/or consult amalgamator manufacturer for recommendations.
10. Do not attempt to place improperly triturated amalgam, or amalgam that has exceeded working time (dry, crumbly).
11. Drilling, polishing and grinding dental fillings should always be combined with water-cooling and suction under a
vacuum.
12. The following precautions are required by the General Director AFSSAPS (Agence française de sécuité sanitaire
des produits de santé – French agency for Sanitary Security of Health Products):
• Store amalgam capsules in a cool and ventilated space.
• Work in ventilated rooms with decontaminable non-textile surfaces.
• Realize shaping and polishing of amalgam always under cooling and suction of the operation field.
• Condense amalgam with classical methods (plugger) and do not use ultrasound condensers.
• Do not place amalgam in direct proximity of other metallic restorations in order to avoid all risk of corrosion.
• Avoid placing and removing amalgam during pregnancy and lactation.
• If local reactions, in particular lichoid lesions in the proximity of amalgam, occur, it is justified to remove the filling.
6. STORAGE
Dispersalloy
®
Amalgam in Self-Activating Capsules should be stored in a well ventilated place at temperature not to
exceed 25ºC/77ºF. Do not allow exposure to moisture or excessive humidity. Do not use after expiration date.
7. ADVERSE REACTIONS
1. Product may irritate skin, eyes. Skin contact: irritation or possible allergic response. Reddish rashes may be seen
on the skin. Eye contact: irritation and possible corneal damage. (See Warnings and Precautions)
2. Inhalation of vapors may cause varying degrees of damage to the affected tissue and also increased susceptibility
to respiratory illness. (See Warnings and Precautions)
3. Product may cause neurotoxic, nephrotoxic or other serious health effects if inhaled or ingested. (See Warnings)
8. STEP-BY-STEP INSTRUCTIONS
1.
Treatment of the preparation:
Clean freshly instrumented enamel and dentin with water spray and then air dry. The
use of pulpal protection, bases and/or cavity liners is at the discretion of the operator, as dictated by the clinical
presentation. If desired, Dispersalloy
®
Amalgam may be placed over an adhesive liner or adhesively bonded by
following the manufacturer’s instructions for compatible adhesive systems (available separately).
2. Trituration: Simply place Dispersalloy
®
Self-Activating Capsules in the amalgamator. These capsules are activated
by the amalgamator – they do not require manual activation. Trituration speed and time is an important factor in
preparing the amalgam, in order to achieve proper amalgam mix consistency. The chart that follows provides
guidelines in determining amalgamator trituration time and speed setting for Dispersalloy
®
Self-Activating
Capsules:
Approximate Trituration Time Range (in seconds) RS = Regular Set / FS = Fast Set
Amalgamator
Speed 1 Spill 2 Spill 3 Spill
FS RS FS RS FS RS
Caulk ProMix
®
Turtle (3700 cpm) 11-17 11-17 11-17 11-17 10-14 10-14
Caulk Vari-Mix
®
II M M2 (3900 cpm) 11-17 11-17 11-17 11-17 10-14 10-14
Caulk Vari-Mix
®
III M (3900 cpm) 11-17 11-17 11-17 11-17 10-14 10-14
Wig-L-Bug MSD 3800 cpm 12-15 12-15 12-15 12-15 10-14 10-14
Wig-L-Bug LPD 3800 cpm 12-15 12-15 12-15 12-15 10-14 10-14
*Kerr AutoMix 4000 cpm 11-17 11-17 11-17 11-17 10-14 10-14
*Pelton & Crane ADEC Model 6440 #7 (4200 cpm) 11-15 11-15 11-15 11-15 10-13 10-13
*Zenith Stirspeed Spirit Model SM 4000 cpm 9-13 10-14 10-15 11-15 10-15 11-15
*Zenith Stirspeed Model TP-103 Fixed 3950 cpm 11-14 10-13 11-14 10-14 10-12 9-12
Model Z-1A H 4100 cpm 10-14 10-14 10-14 10-14 10-13 10-13
*Vivadent Silamat Plus Fast 4700 cpm 6-8 6-8 6-8 6-8 6-8 6-8
*Vivadent Silamat Plus 220V 4000 cpm 8-10 8-10 9-11 9-11 9-11 9-11
*SDI Ultramat 2 4400 cpm 9-12 9-12 9-12 9-12 7-10 7-10
*ESPE CapMix Fixed 4400 cpm 6-7 6-7 6-7 6-7 6-7 6-7
*Torit Capmaster 4200 cpm 13-16 13-16 13-16 13-16 11-15 11-15
The following amalgamators are not recommended for use with Dispersalloy
®
Amalgam in Self-Activating Capsules:
*ESPE Rotamix and *Torit Single Speed Model TRA-18-1
*Not products of DENTSPLY International.
Suggestions for obtaining optimum mix
2.1 The triturated amalgam should be bright and have a plastic consistency. If the amalgam is excessively splashy
and wet looking, INCREASE trituration time or amalgamator speed. Amalgam that appears excessively dry
indicates trituration time or amalgamator speed should be DECREASED.
2.2 When performing adjustments, it is recommended to adjust trituration time in 2 second increments, until
optimum mix is obtained. Greater adjustments may indicate
amalgamator incompatibility or compromised functionality.
Decrease trituration time:
Increase trituration time:
- To lengthen working time - To shorten working time
- If mix is too hot - If mix is too wet
- If mix is too dry
2.3 Properly triturated Dispersalloy
®
Amalgam does not require mulling to produce a smooth plasticity; however
you may mull for 1-2 seconds after removing pestle to
collect amalgam into a single mass.
3. Condensation
3.1 No tool is needed to open the Self-Activating capsule. Just grasp both ends of the capsule, twist, and pull apart.
Turn the opened capsule upside down to drop the amalgam mass into the work area. Dispersalloy
®
Amalgam
is now ready for immediate placement and condensation. A gentle tap may be required to free amalgam from
the capsule. Do not attempt to manually express mercury from the triturated mass prior to placement.
3.2 A plastic wafer and/or plastic mixing pestle may be seen. These have no further function and should be
properly recycled.
0120
3.3 Condense immediately after mix is completed. Use a clean amalgam carrier to transfer increments to the
cavity. Pack each increment into angles and undercuts with small-faced plugger and sufficient pressure to
insure good adaptation. Build the restoration with additional portions, until the cavity is slightly overfilled.
Remove any mercury-rich amalgam from the surface that may develop during condensation.
4.
Carving/Burnishing:
Carving can begin immediately after condensation. A sharp carver will give best results. The
anatomy should be carved proceeding from the proximal margins towards the center of the restoration. Before the
matrix band is removed, the marginal ridge should be supported by a condenser. After removal of the matrix band,
gingival margins may be smoothed with a curved explorer. Burnishing setting amalgam is recommended to improve
surface smoothness.
5.
Polishing:
The quality of the Dispersalloy
®
Amalgam restoration will be enhanced by polishing. The amalgam should
be allowed to set 24 to 48 hours before polishing. See selected polishing instrument manufacturer’s directions for use.
9. LOT NUMBER AND EXPIRATION DATE
1. Do not use after expiration date. ISO standard is used: “YYYY/MM”
2. The following numbers should be quoted in all correspondence:
• Reorder number
• Lot number on package
• Expiration date on package
©2008 DENTSPLY International. All rights reserved. Printed in U.S.A.
Manufactured by:
DENTSPLY Caulk
38 West Clarke Avenue
Milford, DE 19963 U.S.A.
Tel.: 1-302-422-4511
www.dentsply.com
Distributed by:
DENTSPLY Canada
161 Vinyl Court
Woodbridge, Ontario
L4L 4A3 Canada DENTSPLY D
E
T
REY
GmbH
De-Trey-Str. 1
78467 Konstanz
Germany
Tel.: 49-7531-583-0
www.dentsply.de
Form #556018 (R 10/2/08)
A dispersed phase admix amalgam, containing lathe-cut particles and silver/copper eutectic spheres.
1. COMPOSITION
Alloy Powder 1 spill 2 spill 3 spill Weight %
Silver 265 mg 393 mg 528 mg 69%
Tin 69 mg 103 mg 138 mg 18%
Copper 46 mg 69 mg 92 mg 12%
Zinc 4 mg 6 mg 8 mg 1%
Mercury 400 mg 588 mg 782 mg
The recommended alloy to mercury ratio by mass is approximately 1:1.
2. INDICATION FOR USE
Dispersalloy
®
Amalgam is designed for use in stress bearing restorations (Class 1 and 2), when other restorative
materials or restoration techniques are not indicated.
3. CONTRAINDICATION
The use of amalgam is contraindicated in patients with known allergies to amalgams or any of the components.
4. WARNINGS
1. It has been suggested by the Ad-hoc working group established by the European Commission that the
following information, be kept in mind when considering the use of dental amalgams:
• After placement or removal of dental amalgam restorations increased mercury concentration in blood and
urine has been observed. According to available scientific knowledge this increase has not been associated
with any adverse health effects.
• If placed in close contact with other metal restorations galvanic effects may occur. In most cases they will be of
short lasting duration. If the effect persists the user should consider replacement of the dental amalgam filling with
another material.
• There are no proven adverse effects on the fetus associated with the placement or presence of dental amalgam
fillings in the mother. It is sensible, however, where clinically feasible, to minimize health interventions during
pregnancy and avoid any unnecessary chemical exposure of the fetus. This precaution should be observed with
the use of all dental materials.
• It has also been recommended by certain regulatory authorities that consideration be given to the use of amalgam
fillings in children and that amalgams not be used in patients with severe renal disease.
2. Health Canada Warnings:
• Non-mercury filling materials should be considered for restoring the primary teeth of children where the
mechanical properties of the material are suitable.
• Whenever possible, amalgam fillings should not be placed in or removed from the teeth of pregnant women.
• Amalgam should not be placed in patients with impaired kidney function.
• In placing and removing amalgam fillings, dentists should use techniques and equipment to minimize the
exposure of the patient and the dentist to mercury vapor and to prevent amalgam waste from being flushed into
municipal sewage systems.
• Dentists should advise individuals who may have allergic hypersensitivity to mercury to avoid the use of
amalgam. In patients who have developed hypersensitivity to amalgam, existing amalgam restorations should be
replaced with another material where this is recommended by a physician.
3. Alloy amalgam capsule products contain mercury, which can cause skin sensitization or other allergic reaction.
Although the mercury in this product is bound within the amalgam following trituration, proper care should be taken
to prevent exposure to mercury.
Skin Contact: Before using this product wear protective safety glasses, clothing and gloves. If contact with skin
occurs immediately wipe off and flush with generous amounts of water, then wash well with soap and water after
contact. If skin rash, irritation, sensitization or other allergic reaction occurs, discontinue use and seek medical
attention immediately.
Eye Contact: May be irritating to eyes. Before using this product wear protective glasses as well as covering the
patient’s eyes to protect from excess. The use of an enclosed amalgamator is recommended. In case of accidental
contact with eyes, rinse eyes immediately with plenty of water and seek medical attention.
Ingestion: Do not swallow or take internally. Whenever possible, the use of protective
barriers such as rubber dam isolation and protective mask during placement and removal is recommended. If
accidental swallowing occurs, drink lots of water. If nausea or illness develop, seek medical attention immediately.
Contact regional Poison Control Center immediately.
Inhalation: Do not breathe vapor. Whenever possible, the use of protective barriers such as rubber dam isolation,
high-volume evacuation and protective mask during placement and removal is recommended. Give oxygen or
artificial respiration if necessary.
4. Do not open capsule prior to trituration. Do not remove or handle mixing pestle or plastic wafer containing mercury.
5. Do not attempt to clean and/or reuse capsules.
6. THIS ALLOY CONTAINS ZINC; AMALGAM MADE THEREFROM MAY SHOW EXCESSIVE EXPANSION IF
MOISTURE IS INTRODUCED DURING MIXING AND CONDENSING.
5. PRECAUTIONS
1. This product is intended to be used only as specifically outlined in the Directions for Use. Any use of this product
inconsistent with the Directions for Use is at the discretion and sole responsibility of the practitioner.
2. Wear suitable protective eyewear, clothing, mask and gloves. Protective eyewear, and whenever possible, barrier
techniques such as rubber dam is recommended for patients. (See Warnings)
3. Mercury corrodes and embrittles particular metals and their alloys. Avoid unnecessary contact between mercury
and metals.
4. Mercury presents a health hazard if incorrectly handled. Mercury is toxic by vapor inhalation and the effect is
cumulative. Spillages of mercury should be removed immediately, including places which are difficult to access. Use
a plastic syringe to draw it up. Smaller quantities can be covered by sulfur powder and removed. Avoid inhalation of
the vapor.
5. Regulations for disposal must be observed. Adherence to the American Dental Association’s current “Best
Management Practices For Amalgam Waste (BMPs)” and “Dental Mercury Hygiene Recommendations” is strongly
recommended. Among these practices:
• Salvage and store non-contact amalgam scrap in well-sealed containers and recycle.
• Salvage and store contact amalgam pieces from restorations, traps and filters in well-sealed containers and
recycle.
• Do not dispose of amalgam scrap, waste or extracted teeth in regulated infectious waste containers that will be
incinerated, or in regular garbage.
• Recycle used disposable amalgam capsules and plastic wafer (which contained mercury before mixing).
6. Waste material and all primary containers that hold mercury must be disposed of as hazardous waste.
7. DISPERSALLOY
®
AMALGAM CONTAINS ZINC; If moisture is introduced into the amalgam before it has set,
properties such as strength and corrosion resistance may be affected adversely. If the alloy contains zinc, such
contamination may result in an excessive expansion (delayed expansion). Whenever it is possible, use a dry field.
8. Manufacturer’s variation in amalgamators and differences in local electrical current may necessitate adjusting
trituration time to obtain an optimal mix.
9. Insufficient data exist to support the use of amalgamators not listed in the chart below. Use of amalgamators other
than those listed may result in less than optimally triturated amalgam. The operator must investigate non-listed
equipment compatibility and/or consult amalgamator manufacturer for recommendations.
10. Do not attempt to place improperly triturated amalgam, or amalgam that has exceeded working time (dry, crumbly).
11. Drilling, polishing and grinding dental fillings should always be combined with water-cooling and suction under a
vacuum.
12. The following precautions are required by the General Director AFSSAPS (Agence française de sécuité sanitaire
des produits de santé – French agency for Sanitary Security of Health Products):
• Store amalgam capsules in a cool and ventilated space.
• Work in ventilated rooms with decontaminable non-textile surfaces.
• Realize shaping and polishing of amalgam always under cooling and suction of the operation field.
• Condense amalgam with classical methods (plugger) and do not use ultrasound condensers.
• Do not place amalgam in direct proximity of other metallic restorations in order to avoid all risk of corrosion.
• Avoid placing and removing amalgam during pregnancy and lactation.
• If local reactions, in particular lichoid lesions in the proximity of amalgam, occur, it is justified to remove the filling.
6. STORAGE
Dispersalloy
®
Amalgam in Self-Activating Capsules should be stored in a well ventilated place at temperature not to
exceed 25ºC/77ºF. Do not allow exposure to moisture or excessive humidity. Do not use after expiration date.
7. ADVERSE REACTIONS
1. Product may irritate skin, eyes.
Skin contact:
irritation or possible allergic response. Reddish rashes may be seen
on the skin. Eye contact: irritation and possible corneal damage. (See Warnings and Precautions)
2. Inhalation of vapors may cause varying degrees of damage to the affected tissue and also increased susceptibility
to respiratory illness. (See Warnings and Precautions)
3. Product may cause neurotoxic, nephrotoxic or other serious health effects if inhaled or ingested. (See Warnings)
8. STEP-BY-STEP INSTRUCTIONS
1. Treatment of the preparation: Clean freshly instrumented enamel and dentin with water spray and then air dry. The
use of pulpal protection, bases and/or cavity liners is at the discretion of the operator, as dictated by the clinical
presentation. If desired, Dispersalloy
®
Amalgam may be placed over an adhesive liner or adhesively bonded by
following the manufacturer’s instructions for compatible adhesive systems (available separately).
2. Trituration: Simply place Dispersalloy
®
Self-Activating Capsules in the amalgamator. These capsules are activated
by the amalgamator – they do not require manual activation. Trituration speed and time is an important factor in
preparing the amalgam, in order to achieve proper amalgam mix consistency. The chart that follows provides
guidelines in determining amalgamator trituration time and speed setting for Dispersalloy
®
Self-Activating
Capsules:
Approximate Trituration Time Range (in seconds) RS = Regular Set / FS = Fast Set
Amalgamator
Speed 1 Spill 2 Spill 3 Spill
FS RS FS RS FS RS
Caulk ProMix
®
Turtle (3700 cpm) 11-17 11-17 11-17 11-17 10-14 10-14
Caulk Vari-Mix
®
II M M2 (3900 cpm) 11-17 11-17 11-17 11-17 10-14 10-14
Caulk Vari-Mix
®
III M (3900 cpm) 11-17 11-17 11-17 11-17 10-14 10-14
Wig-L-Bug MSD 3800 cpm 12-15 12-15 12-15 12-15 10-14 10-14
Wig-L-Bug LPD 3800 cpm 12-15 12-15 12-15 12-15 10-14 10-14
*Kerr AutoMix 4000 cpm 11-17 11-17 11-17 11-17 10-14 10-14
*Pelton & Crane ADEC Model 6440 #7 (4200 cpm) 11-15 11-15 11-15 11-15 10-13 10-13
*Zenith Stirspeed Spirit Model SM 4000 cpm 9-13 10-14 10-15 11-15 10-15 11-15
*Zenith Stirspeed Model TP-103 Fixed 3950 cpm 11-14 10-13 11-14 10-14 10-12 9-12
Model Z-1A H 4100 cpm 10-14 10-14 10-14 10-14 10-13 10-13
*Vivadent Silamat Plus Fast 4700 cpm 6-8 6-8 6-8 6-8 6-8 6-8
*Vivadent Silamat Plus 220V 4000 cpm 8-10 8-10 9-11 9-11 9-11 9-11
*SDI Ultramat 2 4400 cpm 9-12 9-12 9-12 9-12 7-10 7-10
*ESPE CapMix Fixed 4400 cpm 6-7 6-7 6-7 6-7 6-7 6-7
*Torit Capmaster 4200 cpm 13-16 13-16 13-16 13-16 11-15 11-15
The following amalgamators are not recommended for use with Dispersalloy
®
Amalgam in Self-Activating Capsules:
*ESPE Rotamix and *Torit Single Speed Model TRA-18-1
*Not products of DENTSPLY International.
Suggestions for obtaining optimum mix
2.1 The triturated amalgam should be bright and have a plastic consistency. If the amalgam is excessively splashy
and wet looking, INCREASE trituration time or amalgamator speed. Amalgam that appears excessively dry
indicates trituration time or amalgamator speed should be DECREASED.
2.2 When performing adjustments, it is recommended to adjust trituration time in 2 second increments, until
optimum mix is obtained. Greater adjustments may indicate
amalgamator incompatibility or compromised functionality.
Decrease trituration time:
Increase trituration time:
- To lengthen working time - To shorten working time
- If mix is too hot - If mix is too wet
- If mix is too dry
2.3 Properly triturated Dispersalloy
®
Amalgam does not require mulling to produce a smooth plasticity; however
you may mull for 1-2 seconds after removing pestle to
collect amalgam into a single mass.
3. Condensation
3.1 No tool is needed to open the Self-Activating capsule. Just grasp both ends of the capsule, twist, and pull apart.
Turn the opened capsule upside down to drop the amalgam mass into the work area. Dispersalloy
®
Amalgam
is now ready for immediate placement and condensation. A gentle tap may be required to free amalgam from
the capsule. Do not attempt to manually express mercury from the triturated mass prior to placement.
3.2 A plastic wafer and/or plastic mixing pestle may be seen. These have no further function and should be
properly recycled.
0120
3.3 Condense immediately after mix is completed. Use a clean amalgam carrier to transfer increments to the
cavity. Pack each increment into angles and undercuts with small-faced plugger and sufficient pressure to
insure good adaptation. Build the restoration with additional portions, until the cavity is slightly overfilled.
Remove any mercury-rich amalgam from the surface that may develop during condensation.
4. Carving/Burnishing: Carving can begin immediately after condensation. A sharp carver will give best results. The
anatomy should be carved proceeding from the proximal margins towards the center of the restoration. Before the
matrix band is removed, the marginal ridge should be supported by a condenser. After removal of the matrix band,
gingival margins may be smoothed with a curved explorer. Burnishing setting amalgam is recommended to improve
surface smoothness.
5. Polishing: The quality of the Dispersalloy
®
Amalgam restoration will be enhanced by polishing. The amalgam should
be allowed to set 24 to 48 hours before polishing. See selected polishing instrument manufacturer’s directions for use.
9. LOT NUMBER AND EXPIRATION DATE
1. Do not use after expiration date. ISO standard is used: “YYYY/MM”
2. The following numbers should be quoted in all correspondence:
• Reorder number
• Lot number on package
• Expiration date on package
©2008 DENTSPLY International. All rights reserved. Printed in U.S.A.
Manufactured by:
DENTSPLY Caulk
38 West Clarke Avenue
Milford, DE 19963 U.S.A.
Tel.: 1-302-422-4511
www.dentsply.com
Distributed by:
DENTSPLY Canada
161 Vinyl Court
Woodbridge, Ontario
L4L 4A3 Canada DENTSPLY D
E
T
REY
GmbH
De-Trey-Str. 1
78467 Konstanz
Germany
Tel.: 49-7531-583-0
www.dentsply.de
Form #556018 (R 10/2/08)
A dispersed phase admix amalgam, containing lathe-cut particles and silver/copper eutectic spheres.
1. COMPOSITION
Alloy Powder 1 spill 2 spill 3 spill Weight %
Silver 265 mg 393 mg 528 mg 69%
Tin 69 mg 103 mg 138 mg 18%
Copper 46 mg 69 mg 92 mg 12%
Zinc 4 mg 6 mg 8 mg 1%
Mercury 400 mg 588 mg 782 mg
The recommended alloy to mercury ratio by mass is approximately 1:1.
2. INDICATION FOR USE
Dispersalloy
®
Amalgam is designed for use in stress bearing restorations (Class 1 and 2), when other restorative
materials or restoration techniques are not indicated.
3. CONTRAINDICATION
The use of amalgam is contraindicated in patients with known allergies to amalgams or any of the components.
4. WARNINGS
1. It has been suggested by the Ad-hoc working group established by the European Commission that the
following information, be kept in mind when considering the use of dental amalgams:
• After placement or removal of dental amalgam restorations increased mercury concentration in blood and
urine has been observed. According to available scientific knowledge this increase has not been associated
with any adverse health effects.
• If placed in close contact with other metal restorations galvanic effects may occur. In most cases they will be of
short lasting duration. If the effect persists the user should consider replacement of the dental amalgam filling with
another material.
• There are no proven adverse effects on the fetus associated with the placement or presence of dental amalgam
fillings in the mother. It is sensible, however, where clinically feasible, to minimize health interventions during
pregnancy and avoid any unnecessary chemical exposure of the fetus. This precaution should be observed with
the use of all dental materials.
• It has also been recommended by certain regulatory authorities that consideration be given to the use of amalgam
fillings in children and that amalgams not be used in patients with severe renal disease.
2. Health Canada Warnings:
• Non-mercury filling materials should be considered for restoring the primary teeth of children where the
mechanical properties of the material are suitable.
• Whenever possible, amalgam fillings should not be placed in or removed from the teeth of pregnant women.
• Amalgam should not be placed in patients with impaired kidney function.
• In placing and removing amalgam fillings, dentists should use techniques and equipment to minimize the
exposure of the patient and the dentist to mercury vapor and to prevent amalgam waste from being flushed into
municipal sewage systems.
• Dentists should advise individuals who may have allergic hypersensitivity to mercury to avoid the use of
amalgam. In patients who have developed hypersensitivity to amalgam, existing amalgam restorations should be
replaced with another material where this is recommended by a physician.
3. Alloy amalgam capsule products contain mercury, which can cause skin sensitization or other allergic reaction.
Although the mercury in this product is bound within the amalgam following trituration, proper care should be taken
to prevent exposure to mercury.
Skin Contact: Before using this product wear protective safety glasses, clothing and gloves. If contact with skin
occurs immediately wipe off and flush with generous amounts of water, then wash well with soap and water after
contact. If skin rash, irritation, sensitization or other allergic reaction occurs, discontinue use and seek medical
attention immediately.
Eye Contact: May be irritating to eyes. Before using this product wear protective glasses as well as covering the
patient’s eyes to protect from excess. The use of an enclosed amalgamator is recommended. In case of accidental
contact with eyes, rinse eyes immediately with plenty of water and seek medical attention.
Ingestion: Do not swallow or take internally. Whenever possible, the use of protective
barriers such as rubber dam isolation and protective mask during placement and removal is recommended. If
accidental swallowing occurs, drink lots of water. If nausea or illness develop, seek medical attention immediately.
Contact regional Poison Control Center immediately.
Inhalation:
Do not breathe vapor. Whenever possible, the use of protective barriers such as rubber dam isolation,
high-volume evacuation and protective mask during placement and removal is recommended. Give oxygen or
artificial respiration if necessary.
4. Do not open capsule prior to trituration. Do not remove or handle mixing pestle or plastic wafer containing mercury.
5. Do not attempt to clean and/or reuse capsules.
6. THIS ALLOY CONTAINS ZINC; AMALGAM MADE THEREFROM MAY SHOW EXCESSIVE EXPANSION IF
MOISTURE IS INTRODUCED DURING MIXING AND CONDENSING.
5. PRECAUTIONS
1. This product is intended to be used only as specifically outlined in the
Directions for Use.
Any use of this product
inconsistent with the Directions for Use is at the discretion and sole responsibility of the practitioner.
2. Wear suitable protective eyewear, clothing, mask and gloves. Protective eyewear, and whenever possible, barrier
techniques such as rubber dam is recommended for patients. (See Warnings)
3. Mercury corrodes and embrittles particular metals and their alloys. Avoid unnecessary contact between mercury
and metals.
4. Mercury presents a health hazard if incorrectly handled. Mercury is toxic by vapor inhalation and the effect is
cumulative. Spillages of mercury should be removed immediately, including places which are difficult to access. Use
a plastic syringe to draw it up. Smaller quantities can be covered by sulfur powder and removed. Avoid inhalation of
the vapor.
5. Regulations for disposal must be observed. Adherence to the American Dental Association’s current “Best
Management Practices For Amalgam Waste (BMPs)” and “Dental Mercury Hygiene Recommendations” is strongly
recommended. Among these practices:
• Salvage and store non-contact amalgam scrap in well-sealed containers and recycle.
• Salvage and store contact amalgam pieces from restorations, traps and filters in well-sealed containers and
recycle.
• Do not dispose of amalgam scrap, waste or extracted teeth in regulated infectious waste containers that will be
incinerated, or in regular garbage.
• Recycle used disposable amalgam capsules and plastic wafer (which contained mercury before mixing).
6. Waste material and all primary containers that hold mercury must be disposed of as hazardous waste.
7. DISPERSALLOY
®
AMALGAM CONTAINS ZINC; If moisture is introduced into the amalgam before it has set,
properties such as strength and corrosion resistance may be affected adversely. If the alloy contains zinc, such
contamination may result in an excessive expansion (delayed expansion). Whenever it is possible, use a dry field.
8. Manufacturer’s variation in amalgamators and differences in local electrical current may necessitate adjusting
trituration time to obtain an optimal mix.
9. Insufficient data exist to support the use of amalgamators not listed in the chart below. Use of amalgamators other
than those listed may result in less than optimally triturated amalgam. The operator must investigate non-listed
equipment compatibility and/or consult amalgamator manufacturer for recommendations.
10. Do not attempt to place improperly triturated amalgam, or amalgam that has exceeded working time (dry, crumbly).
11. Drilling, polishing and grinding dental fillings should always be combined with water-cooling and suction under a
vacuum.
12. The following precautions are required by the General Director AFSSAPS (Agence française de sécuité sanitaire
des produits de santé – French agency for Sanitary Security of Health Products):
• Store amalgam capsules in a cool and ventilated space.
• Work in ventilated rooms with decontaminable non-textile surfaces.
• Realize shaping and polishing of amalgam always under cooling and suction of the operation field.
• Condense amalgam with classical methods (plugger) and do not use ultrasound condensers.
• Do not place amalgam in direct proximity of other metallic restorations in order to avoid all risk of corrosion.
• Avoid placing and removing amalgam during pregnancy and lactation.
• If local reactions, in particular lichoid lesions in the proximity of amalgam, occur, it is justified to remove the filling.
6. STORAGE
Dispersalloy
®
Amalgam in Self-Activating Capsules should be stored in a well ventilated place at temperature not to
exceed 25ºC/77ºF. Do not allow exposure to moisture or excessive humidity. Do not use after expiration date.
7. ADVERSE REACTIONS
1. Product may irritate skin, eyes. Skin contact: irritation or possible allergic response. Reddish rashes may be seen
on the skin. Eye contact: irritation and possible corneal damage. (See Warnings and Precautions)
2. Inhalation of vapors may cause varying degrees of damage to the affected tissue and also increased susceptibility
to respiratory illness. (See Warnings and Precautions)
3. Product may cause neurotoxic, nephrotoxic or other serious health effects if inhaled or ingested. (See Warnings)
8. STEP-BY-STEP INSTRUCTIONS
1. Treatment of the preparation: Clean freshly instrumented enamel and dentin with water spray and then air dry. The
use of pulpal protection, bases and/or cavity liners is at the discretion of the operator, as dictated by the clinical
presentation. If desired, Dispersalloy
®
Amalgam may be placed over an adhesive liner or adhesively bonded by
following the manufacturer’s instructions for compatible adhesive systems (available separately).
2.
Trituration:
Simply place Dispersalloy
®
Self-Activating Capsules in the amalgamator. These capsules are activated
by the amalgamator – they do not require manual activation. Trituration speed and time is an important factor in
preparing the amalgam, in order to achieve proper amalgam mix consistency. The chart that follows provides
guidelines in determining amalgamator trituration time and speed setting for Dispersalloy
®
Self-Activating
Capsules:
Approximate Trituration Time Range (in seconds) RS = Regular Set / FS = Fast Set
Amalgamator Speed 1 Spill 2 Spill 3 Spill
FS RS FS RS FS RS
Caulk ProMix
®
Turtle (3700 cpm) 11-17 11-17 11-17 11-17 10-14 10-14
Caulk Vari-Mix
®
II M M2 (3900 cpm) 11-17 11-17 11-17 11-17 10-14 10-14
Caulk Vari-Mix
®
III M (3900 cpm) 11-17 11-17 11-17 11-17 10-14 10-14
Wig-L-Bug MSD 3800 cpm 12-15 12-15 12-15 12-15 10-14 10-14
Wig-L-Bug LPD 3800 cpm 12-15 12-15 12-15 12-15 10-14 10-14
*Kerr AutoMix 4000 cpm 11-17 11-17 11-17 11-17 10-14 10-14
*Pelton & Crane ADEC Model 6440 #7 (4200 cpm) 11-15 11-15 11-15 11-15 10-13 10-13
*Zenith Stirspeed Spirit Model SM 4000 cpm 9-13 10-14 10-15 11-15 10-15 11-15
*Zenith Stirspeed Model TP-103 Fixed 3950 cpm 11-14 10-13 11-14 10-14 10-12 9-12
Model Z-1A H 4100 cpm 10-14 10-14 10-14 10-14 10-13 10-13
*Vivadent Silamat Plus Fast 4700 cpm 6-8 6-8 6-8 6-8 6-8 6-8
*Vivadent Silamat Plus 220V 4000 cpm 8-10 8-10 9-11 9-11 9-11 9-11
*SDI Ultramat 2 4400 cpm 9-12 9-12 9-12 9-12 7-10 7-10
*ESPE CapMix Fixed 4400 cpm 6-7 6-7 6-7 6-7 6-7 6-7
*Torit Capmaster 4200 cpm 13-16 13-16 13-16 13-16 11-15 11-15
The following amalgamators are not recommended for use with Dispersalloy
®
Amalgam in Self-Activating Capsules:
*ESPE Rotamix and *Torit Single Speed Model TRA-18-1
*Not products of DENTSPLY International.
Suggestions for obtaining optimum mix
2.1 The triturated amalgam should be bright and have a plastic consistency. If the amalgam is excessively splashy
and wet looking, INCREASE trituration time or amalgamator speed. Amalgam that appears excessively dry
indicates trituration time or amalgamator speed should be DECREASED.
2.2 When performing adjustments, it is recommended to adjust trituration time in 2 second increments, until
optimum mix is obtained. Greater adjustments may indicate
amalgamator incompatibility or compromised functionality.
Decrease trituration time:
Increase trituration time:
- To lengthen working time - To shorten working time
- If mix is too hot - If mix is too wet
- If mix is too dry
2.3 Properly triturated Dispersalloy
®
Amalgam does not require mulling to produce a smooth plasticity; however
you may mull for 1-2 seconds after removing pestle to
collect amalgam into a single mass.
3.
Condensation
3.1 No tool is needed to open the Self-Activating capsule. Just grasp both ends of the capsule, twist, and pull apart.
Turn the opened capsule upside down to drop the amalgam mass into the work area. Dispersalloy
®
Amalgam
is now ready for immediate placement and condensation. A gentle tap may be required to free amalgam from
the capsule. Do not attempt to manually express mercury from the triturated mass prior to placement.
3.2 A plastic wafer and/or plastic mixing pestle may be seen. These have no further function and should be
properly recycled.
0120
3.3 Condense immediately after mix is completed. Use a clean amalgam carrier to transfer increments to the
cavity. Pack each increment into angles and undercuts with small-faced plugger and sufficient pressure to
insure good adaptation. Build the restoration with additional portions, until the cavity is slightly overfilled.
Remove any mercury-rich amalgam from the surface that may develop during condensation.
4. Carving/Burnishing: Carving can begin immediately after condensation. A sharp carver will give best results. The
anatomy should be carved proceeding from the proximal margins towards the center of the restoration. Before the
matrix band is removed, the marginal ridge should be supported by a condenser. After removal of the matrix band,
gingival margins may be smoothed with a curved explorer. Burnishing setting amalgam is recommended to improve
surface smoothness.
5. Polishing: The quality of the Dispersalloy
®
Amalgam restoration will be enhanced by polishing. The amalgam should
be allowed to set 24 to 48 hours before polishing. See selected polishing instrument manufacturer’s directions for use.
9. LOT NUMBER AND EXPIRATION DATE
1. Do not use after expiration date. ISO standard is used: “YYYY/MM”
2. The following numbers should be quoted in all correspondence:
• Reorder number
• Lot number on package
• Expiration date on package
©2008 DENTSPLY International. All rights reserved. Printed in U.S.A.
Manufactured by:
DENTSPLY Caulk
38 West Clarke Avenue
Milford, DE 19963 U.S.A.
Tel.: 1-302-422-4511
www.dentsply.com
Distributed by:
DENTSPLY Canada
161 Vinyl Court
Woodbridge, Ontario
L4L 4A3 Canada DENTSPLY D
E
T
REY
GmbH
De-Trey-Str. 1
78467 Konstanz
Germany
Tel.: 49-7531-583-0
www.dentsply.de
Form #556018 (R 10/2/08)
A dispersed phase admix amalgam, containing lathe-cut particles and silver/copper eutectic spheres.
1. COMPOSITION
Alloy Powder 1 spill 2 spill 3 spill Weight %
Silver 265 mg 393 mg 528 mg 69%
Tin 69 mg 103 mg 138 mg 18%
Copper 46 mg 69 mg 92 mg 12%
Zinc 4 mg 6 mg 8 mg 1%
Mercury 400 mg 588 mg 782 mg
The recommended alloy to mercury ratio by mass is approximately 1:1.
2. INDICATION FOR USE
Dispersalloy
®
Amalgam is designed for use in stress bearing restorations (Class 1 and 2), when other restorative
materials or restoration techniques are not indicated.
3. CONTRAINDICATION
The use of amalgam is contraindicated in patients with known allergies to amalgams or any of the components.
4. WARNINGS
1. It has been suggested by the Ad-hoc working group established by the European Commission that the
following information, be kept in mind when considering the use of dental amalgams:
• After placement or removal of dental amalgam restorations increased mercury concentration in blood and
urine has been observed. According to available scientific knowledge this increase has not been associated
with any adverse health effects.
• If placed in close contact with other metal restorations galvanic effects may occur. In most cases they will be of
short lasting duration. If the effect persists the user should consider replacement of the dental amalgam filling with
another material.
• There are no proven adverse effects on the fetus associated with the placement or presence of dental amalgam
fillings in the mother. It is sensible, however, where clinically feasible, to minimize health interventions during
pregnancy and avoid any unnecessary chemical exposure of the fetus. This precaution should be observed with
the use of all dental materials.
• It has also been recommended by certain regulatory authorities that consideration be given to the use of amalgam
fillings in children and that amalgams not be used in patients with severe renal disease.
2. Health Canada Warnings:
• Non-mercury filling materials should be considered for restoring the primary teeth of children where the
mechanical properties of the material are suitable.
• Whenever possible, amalgam fillings should not be placed in or removed from the teeth of pregnant women.
• Amalgam should not be placed in patients with impaired kidney function.
• In placing and removing amalgam fillings, dentists should use techniques and equipment to minimize the
exposure of the patient and the dentist to mercury vapor and to prevent amalgam waste from being flushed into
municipal sewage systems.
• Dentists should advise individuals who may have allergic hypersensitivity to mercury to avoid the use of
amalgam. In patients who have developed hypersensitivity to amalgam, existing amalgam restorations should be
replaced with another material where this is recommended by a physician.
3. Alloy amalgam capsule products contain mercury, which can cause skin sensitization or other allergic reaction.
Although the mercury in this product is bound within the amalgam following trituration, proper care should be taken
to prevent exposure to mercury.
Skin Contact: Before using this product wear protective safety glasses, clothing and gloves. If contact with skin
occurs immediately wipe off and flush with generous amounts of water, then wash well with soap and water after
contact. If skin rash, irritation, sensitization or other allergic reaction occurs, discontinue use and seek medical
attention immediately.
Eye Contact: May be irritating to eyes. Before using this product wear protective glasses as well as covering the
patient’s eyes to protect from excess. The use of an enclosed amalgamator is recommended. In case of accidental
contact with eyes, rinse eyes immediately with plenty of water and seek medical attention.
Ingestion: Do not swallow or take internally. Whenever possible, the use of protective
barriers such as rubber dam isolation and protective mask during placement and removal is recommended. If
accidental swallowing occurs, drink lots of water. If nausea or illness develop, seek medical attention immediately.
Contact regional Poison Control Center immediately.
Inhalation:
Do not breathe vapor. Whenever possible, the use of protective barriers such as rubber dam isolation,
high-volume evacuation and protective mask during placement and removal is recommended. Give oxygen or
artificial respiration if necessary.
4. Do not open capsule prior to trituration. Do not remove or handle mixing pestle or plastic wafer containing mercury.
5. Do not attempt to clean and/or reuse capsules.
6. THIS ALLOY CONTAINS ZINC; AMALGAM MADE THEREFROM MAY SHOW EXCESSIVE EXPANSION IF
MOISTURE IS INTRODUCED DURING MIXING AND CONDENSING.
5. PRECAUTIONS
1. This product is intended to be used only as specifically outlined in the
Directions for Use.
Any use of this product
inconsistent with the Directions for Use is at the discretion and sole responsibility of the practitioner.
2. Wear suitable protective eyewear, clothing, mask and gloves. Protective eyewear, and whenever possible, barrier
techniques such as rubber dam is recommended for patients. (See Warnings)
3. Mercury corrodes and embrittles particular metals and their alloys. Avoid unnecessary contact between mercury
and metals.
4. Mercury presents a health hazard if incorrectly handled. Mercury is toxic by vapor inhalation and the effect is
cumulative. Spillages of mercury should be removed immediately, including places which are difficult to access. Use
a plastic syringe to draw it up. Smaller quantities can be covered by sulfur powder and removed. Avoid inhalation of
the vapor.
5. Regulations for disposal must be observed. Adherence to the American Dental Association’s current “Best
Management Practices For Amalgam Waste (BMPs)” and “Dental Mercury Hygiene Recommendations” is strongly
recommended. Among these practices:
• Salvage and store non-contact amalgam scrap in well-sealed containers and recycle.
• Salvage and store contact amalgam pieces from restorations, traps and filters in well-sealed containers and
recycle.
• Do not dispose of amalgam scrap, waste or extracted teeth in regulated infectious waste containers that will be
incinerated, or in regular garbage.
• Recycle used disposable amalgam capsules and plastic wafer (which contained mercury before mixing).
6. Waste material and all primary containers that hold mercury must be disposed of as hazardous waste.
7. DISPERSALLOY
®
AMALGAM CONTAINS ZINC; If moisture is introduced into the amalgam before it has set,
properties such as strength and corrosion resistance may be affected adversely. If the alloy contains zinc, such
contamination may result in an excessive expansion (delayed expansion). Whenever it is possible, use a dry field.
8. Manufacturer’s variation in amalgamators and differences in local electrical current may necessitate adjusting
trituration time to obtain an optimal mix.
9. Insufficient data exist to support the use of amalgamators not listed in the chart below. Use of amalgamators other
than those listed may result in less than optimally triturated amalgam. The operator must investigate non-listed
equipment compatibility and/or consult amalgamator manufacturer for recommendations.
10. Do not attempt to place improperly triturated amalgam, or amalgam that has exceeded working time (dry, crumbly).
11. Drilling, polishing and grinding dental fillings should always be combined with water-cooling and suction under a
vacuum.
12. The following precautions are required by the General Director AFSSAPS (Agence française de sécuité sanitaire
des produits de santé – French agency for Sanitary Security of Health Products):
• Store amalgam capsules in a cool and ventilated space.
• Work in ventilated rooms with decontaminable non-textile surfaces.
• Realize shaping and polishing of amalgam always under cooling and suction of the operation field.
• Condense amalgam with classical methods (plugger) and do not use ultrasound condensers.
• Do not place amalgam in direct proximity of other metallic restorations in order to avoid all risk of corrosion.
• Avoid placing and removing amalgam during pregnancy and lactation.
• If local reactions, in particular lichoid lesions in the proximity of amalgam, occur, it is justified to remove the filling.
6. STORAGE
Dispersalloy
®
Amalgam in Self-Activating Capsules should be stored in a well ventilated place at temperature not to
exceed 25ºC/77ºF. Do not allow exposure to moisture or excessive humidity. Do not use after expiration date.
7. ADVERSE REACTIONS
1. Product may irritate skin, eyes. Skin contact: irritation or possible allergic response. Reddish rashes may be seen
on the skin. Eye contact: irritation and possible corneal damage. (See Warnings and Precautions)
2. Inhalation of vapors may cause varying degrees of damage to the affected tissue and also increased susceptibility
to respiratory illness. (See Warnings and Precautions)
3. Product may cause neurotoxic, nephrotoxic or other serious health effects if inhaled or ingested. (See Warnings)
8. STEP-BY-STEP INSTRUCTIONS
1. Treatment of the preparation: Clean freshly instrumented enamel and dentin with water spray and then air dry. The
use of pulpal protection, bases and/or cavity liners is at the discretion of the operator, as dictated by the clinical
presentation. If desired, Dispersalloy
®
Amalgam may be placed over an adhesive liner or adhesively bonded by
following the manufacturer’s instructions for compatible adhesive systems (available separately).
2.
Trituration:
Simply place Dispersalloy
®
Self-Activating Capsules in the amalgamator. These capsules are activated
by the amalgamator – they do not require manual activation. Trituration speed and time is an important factor in
preparing the amalgam, in order to achieve proper amalgam mix consistency. The chart that follows provides
guidelines in determining amalgamator trituration time and speed setting for Dispersalloy
®
Self-Activating
Capsules:
Approximate Trituration Time Range (in seconds) RS = Regular Set / FS = Fast Set
Amalgamator
Speed 1 Spill 2 Spill 3 Spill
FS RS FS RS FS RS
Caulk ProMix
®
Turtle (3700 cpm) 11-17 11-17 11-17 11-17 10-14 10-14
Caulk Vari-Mix
®
II M M2 (3900 cpm) 11-17 11-17 11-17 11-17 10-14 10-14
Caulk Vari-Mix
®
III M (3900 cpm) 11-17 11-17 11-17 11-17 10-14 10-14
Wig-L-Bug MSD 3800 cpm 12-15 12-15 12-15 12-15 10-14 10-14
Wig-L-Bug LPD 3800 cpm 12-15 12-15 12-15 12-15 10-14 10-14
*Kerr AutoMix 4000 cpm 11-17 11-17 11-17 11-17 10-14 10-14
*Pelton & Crane ADEC Model 6440 #7 (4200 cpm) 11-15 11-15 11-15 11-15 10-13 10-13
*Zenith Stirspeed Spirit Model SM 4000 cpm 9-13 10-14 10-15 11-15 10-15 11-15
*Zenith Stirspeed Model TP-103 Fixed 3950 cpm 11-14 10-13 11-14 10-14 10-12 9-12
Model Z-1A H 4100 cpm 10-14 10-14 10-14 10-14 10-13 10-13
*Vivadent Silamat Plus Fast 4700 cpm 6-8 6-8 6-8 6-8 6-8 6-8
*Vivadent Silamat Plus 220V 4000 cpm 8-10 8-10 9-11 9-11 9-11 9-11
*SDI Ultramat 2 4400 cpm 9-12 9-12 9-12 9-12 7-10 7-10
*ESPE CapMix Fixed 4400 cpm 6-7 6-7 6-7 6-7 6-7 6-7
*Torit Capmaster 4200 cpm 13-16 13-16 13-16 13-16 11-15 11-15
The following amalgamators are not recommended for use with Dispersalloy
®
Amalgam in Self-Activating Capsules:
*ESPE Rotamix and *Torit Single Speed Model TRA-18-1
*Not products of DENTSPLY International.
Suggestions for obtaining optimum mix
2.1 The triturated amalgam should be bright and have a plastic consistency. If the amalgam is excessively splashy
and wet looking, INCREASE trituration time or amalgamator speed. Amalgam that appears excessively dry
indicates trituration time or amalgamator speed should be DECREASED.
2.2 When performing adjustments, it is recommended to adjust trituration time in 2 second increments, until
optimum mix is obtained. Greater adjustments may indicate
amalgamator incompatibility or compromised functionality.
Decrease trituration time:
Increase trituration time:
- To lengthen working time - To shorten working time
- If mix is too hot - If mix is too wet
- If mix is too dry
2.3 Properly triturated Dispersalloy
®
Amalgam does not require mulling to produce a smooth plasticity; however
you may mull for 1-2 seconds after removing pestle to
collect amalgam into a single mass.
3.
Condensation
3.1 No tool is needed to open the Self-Activating capsule. Just grasp both ends of the capsule, twist, and pull apart.
Turn the opened capsule upside down to drop the amalgam mass into the work area. Dispersalloy
®
Amalgam
is now ready for immediate placement and condensation. A gentle tap may be required to free amalgam from
the capsule. Do not attempt to manually express mercury from the triturated mass prior to placement.
3.2 A plastic wafer and/or plastic mixing pestle may be seen. These have no further function and should be
properly recycled.
0120
3.3 Condense immediately after mix is completed. Use a clean amalgam carrier to transfer increments to the
cavity. Pack each increment into angles and undercuts with small-faced plugger and sufficient pressure to
insure good adaptation. Build the restoration with additional portions, until the cavity is slightly overfilled.
Remove any mercury-rich amalgam from the surface that may develop during condensation.
4. Carving/Burnishing: Carving can begin immediately after condensation. A sharp carver will give best results. The
anatomy should be carved proceeding from the proximal margins towards the center of the restoration. Before the
matrix band is removed, the marginal ridge should be supported by a condenser. After removal of the matrix band,
gingival margins may be smoothed with a curved explorer. Burnishing setting amalgam is recommended to improve
surface smoothness.
5. Polishing: The quality of the Dispersalloy
®
Amalgam restoration will be enhanced by polishing. The amalgam should
be allowed to set 24 to 48 hours before polishing. See selected polishing instrument manufacturer’s directions for use.
9. LOT NUMBER AND EXPIRATION DATE
1. Do not use after expiration date. ISO standard is used: “YYYY/MM”
2. The following numbers should be quoted in all correspondence:
• Reorder number
• Lot number on package
• Expiration date on package
©2008 DENTSPLY International. All rights reserved. Printed in U.S.A.
Manufactured by:
DENTSPLY Caulk
38 West Clarke Avenue
Milford, DE 19963 U.S.A.
Tel.: 1-302-422-4511
www.dentsply.com
Distributed by:
DENTSPLY Canada
161 Vinyl Court
Woodbridge, Ontario
L4L 4A3 Canada DENTSPLY D
E
T
REY
GmbH
De-Trey-Str. 1
78467 Konstanz
Germany
Tel.: 49-7531-583-0
www.dentsply.de
Form #556018 (R 10/2/08)
A dispersed phase admix amalgam, containing lathe-cut particles and silver/copper eutectic spheres.
1. COMPOSITION
Alloy Powder 1 spill 2 spill 3 spill Weight %
Silver 265 mg 393 mg 528 mg 69%
Tin 69 mg 103 mg 138 mg 18%
Copper 46 mg 69 mg 92 mg 12%
Zinc 4 mg 6 mg 8 mg 1%
Mercury 400 mg 588 mg 782 mg
The recommended alloy to mercury ratio by mass is approximately 1:1.
2. INDICATION FOR USE
Dispersalloy
®
Amalgam is designed for use in stress bearing restorations (Class 1 and 2), when other restorative
materials or restoration techniques are not indicated.
3. CONTRAINDICATION
The use of amalgam is contraindicated in patients with known allergies to amalgams or any of the components.
4. WARNINGS
1. It has been suggested by the Ad-hoc working group established by the European Commission that the
following information, be kept in mind when considering the use of dental amalgams:
• After placement or removal of dental amalgam restorations increased mercury concentration in blood and
urine has been observed. According to available scientific knowledge this increase has not been associated
with any adverse health effects.
• If placed in close contact with other metal restorations galvanic effects may occur. In most cases they will be of
short lasting duration. If the effect persists the user should consider replacement of the dental amalgam filling with
another material.
• There are no proven adverse effects on the fetus associated with the placement or presence of dental amalgam
fillings in the mother. It is sensible, however, where clinically feasible, to minimize health interventions during
pregnancy and avoid any unnecessary chemical exposure of the fetus. This precaution should be observed with
the use of all dental materials.
• It has also been recommended by certain regulatory authorities that consideration be given to the use of amalgam
fillings in children and that amalgams not be used in patients with severe renal disease.
2. Health Canada Warnings:
• Non-mercury filling materials should be considered for restoring the primary teeth of children where the
mechanical properties of the material are suitable.
• Whenever possible, amalgam fillings should not be placed in or removed from the teeth of pregnant women.
• Amalgam should not be placed in patients with impaired kidney function.
• In placing and removing amalgam fillings, dentists should use techniques and equipment to minimize the
exposure of the patient and the dentist to mercury vapor and to prevent amalgam waste from being flushed into
municipal sewage systems.
• Dentists should advise individuals who may have allergic hypersensitivity to mercury to avoid the use of
amalgam. In patients who have developed hypersensitivity to amalgam, existing amalgam restorations should be
replaced with another material where this is recommended by a physician.
3. Alloy amalgam capsule products contain mercury, which can cause skin sensitization or other allergic reaction.
Although the mercury in this product is bound within the amalgam following trituration, proper care should be taken
to prevent exposure to mercury.
Skin Contact: Before using this product wear protective safety glasses, clothing and gloves. If contact with skin
occurs immediately wipe off and flush with generous amounts of water, then wash well with soap and water after
contact. If skin rash, irritation, sensitization or other allergic reaction occurs, discontinue use and seek medical
attention immediately.
Eye Contact: May be irritating to eyes. Before using this product wear protective glasses as well as covering the
patient’s eyes to protect from excess. The use of an enclosed amalgamator is recommended. In case of accidental
contact with eyes, rinse eyes immediately with plenty of water and seek medical attention.
Ingestion: Do not swallow or take internally. Whenever possible, the use of protective
barriers such as rubber dam isolation and protective mask during placement and removal is recommended. If
accidental swallowing occurs, drink lots of water. If nausea or illness develop, seek medical attention immediately.
Contact regional Poison Control Center immediately.
Inhalation: Do not breathe vapor. Whenever possible, the use of protective barriers such as rubber dam isolation,
high-volume evacuation and protective mask during placement and removal is recommended. Give oxygen or
artificial respiration if necessary.
4. Do not open capsule prior to trituration. Do not remove or handle mixing pestle or plastic wafer containing mercury.
5. Do not attempt to clean and/or reuse capsules.
6. THIS ALLOY CONTAINS ZINC; AMALGAM MADE THEREFROM MAY SHOW EXCESSIVE EXPANSION IF
MOISTURE IS INTRODUCED DURING MIXING AND CONDENSING.
5. PRECAUTIONS
1. This product is intended to be used only as specifically outlined in the Directions for Use. Any use of this product
inconsistent with the Directions for Use is at the discretion and sole responsibility of the practitioner.
2. Wear suitable protective eyewear, clothing, mask and gloves. Protective eyewear, and whenever possible, barrier
techniques such as rubber dam is recommended for patients. (See Warnings)
3. Mercury corrodes and embrittles particular metals and their alloys. Avoid unnecessary contact between mercury
and metals.
4. Mercury presents a health hazard if incorrectly handled. Mercury is toxic by vapor inhalation and the effect is
cumulative. Spillages of mercury should be removed immediately, including places which are difficult to access. Use
a plastic syringe to draw it up. Smaller quantities can be covered by sulfur powder and removed. Avoid inhalation of
the vapor.
5. Regulations for disposal must be observed. Adherence to the American Dental Association’s current “Best
Management Practices For Amalgam Waste (BMPs)” and “Dental Mercury Hygiene Recommendations” is strongly
recommended. Among these practices:
• Salvage and store non-contact amalgam scrap in well-sealed containers and recycle.
• Salvage and store contact amalgam pieces from restorations, traps and filters in well-sealed containers and
recycle.
• Do not dispose of amalgam scrap, waste or extracted teeth in regulated infectious waste containers that will be
incinerated, or in regular garbage.
• Recycle used disposable amalgam capsules and plastic wafer (which contained mercury before mixing).
6. Waste material and all primary containers that hold mercury must be disposed of as hazardous waste.
7. DISPERSALLOY
®
AMALGAM CONTAINS ZINC; If moisture is introduced into the amalgam before it has set,
properties such as strength and corrosion resistance may be affected adversely. If the alloy contains zinc, such
contamination may result in an excessive expansion (delayed expansion). Whenever it is possible, use a dry field.
8. Manufacturer’s variation in amalgamators and differences in local electrical current may necessitate adjusting
trituration time to obtain an optimal mix.
9. Insufficient data exist to support the use of amalgamators not listed in the chart below. Use of amalgamators other
than those listed may result in less than optimally triturated amalgam. The operator must investigate non-listed
equipment compatibility and/or consult amalgamator manufacturer for recommendations.
10. Do not attempt to place improperly triturated amalgam, or amalgam that has exceeded working time (dry, crumbly).
11. Drilling, polishing and grinding dental fillings should always be combined with water-cooling and suction under a
vacuum.
12. The following precautions are required by the General Director AFSSAPS (Agence française de sécuité sanitaire
des produits de santé – French agency for Sanitary Security of Health Products):
• Store amalgam capsules in a cool and ventilated space.
• Work in ventilated rooms with decontaminable non-textile surfaces.
• Realize shaping and polishing of amalgam always under cooling and suction of the operation field.
• Condense amalgam with classical methods (plugger) and do not use ultrasound condensers.
• Do not place amalgam in direct proximity of other metallic restorations in order to avoid all risk of corrosion.
• Avoid placing and removing amalgam during pregnancy and lactation.
• If local reactions, in particular lichoid lesions in the proximity of amalgam, occur, it is justified to remove the filling.
6. STORAGE
Dispersalloy
®
Amalgam in Self-Activating Capsules should be stored in a well ventilated place at temperature not to
exceed 25ºC/77ºF. Do not allow exposure to moisture or excessive humidity. Do not use after expiration date.
7. ADVERSE REACTIONS
1. Product may irritate skin, eyes.
Skin contact: irritation or possible allergic response. Reddish rashes may be seen
on the skin. Eye contact: irritation and possible corneal damage. (See Warnings and Precautions)
2. Inhalation of vapors may cause varying degrees of damage to the affected tissue and also increased susceptibility
to respiratory illness. (See Warnings and Precautions)
3. Product may cause neurotoxic, nephrotoxic or other serious health effects if inhaled or ingested. (See Warnings)
8. STEP-BY-STEP INSTRUCTIONS
1. Treatment of the preparation: Clean freshly instrumented enamel and dentin with water spray and then air dry. The
use of pulpal protection, bases and/or cavity liners is at the discretion of the operator, as dictated by the clinical
presentation. If desired, Dispersalloy
®
Amalgam may be placed over an adhesive liner or adhesively bonded by
following the manufacturer’s instructions for compatible adhesive systems (available separately).
2. Trituration: Simply place Dispersalloy
®
Self-Activating Capsules in the amalgamator. These capsules are activated
by the amalgamator – they do not require manual activation. Trituration speed and time is an important factor in
preparing the amalgam, in order to achieve proper amalgam mix consistency. The chart that follows provides
guidelines in determining amalgamator trituration time and speed setting for Dispersalloy
®
Self-Activating
Capsules:
Approximate Trituration Time Range (in seconds) RS = Regular Set / FS = Fast Set
Amalgamator Speed 1 Spill 2 Spill 3 Spill
FS RS FS RS FS RS
Caulk ProMix
®
Turtle (3700 cpm) 11-17 11-17 11-17 11-17 10-14 10-14
Caulk Vari-Mix
®
II M M2 (3900 cpm) 11-17 11-17 11-17 11-17 10-14 10-14
Caulk Vari-Mix
®
III M (3900 cpm) 11-17 11-17 11-17 11-17 10-14 10-14
Wig-L-Bug MSD 3800 cpm 12-15 12-15 12-15 12-15 10-14 10-14
Wig-L-Bug LPD 3800 cpm 12-15 12-15 12-15 12-15 10-14 10-14
*Kerr AutoMix 4000 cpm 11-17 11-17 11-17 11-17 10-14 10-14
*Pelton & Crane ADEC Model 6440 #7 (4200 cpm) 11-15 11-15 11-15 11-15 10-13 10-13
*Zenith Stirspeed Spirit Model SM 4000 cpm 9-13 10-14 10-15 11-15 10-15 11-15
*Zenith Stirspeed Model TP-103 Fixed 3950 cpm 11-14 10-13 11-14 10-14 10-12 9-12
Model Z-1A H 4100 cpm 10-14 10-14 10-14 10-14 10-13 10-13
*Vivadent Silamat Plus Fast 4700 cpm 6-8 6-8 6-8 6-8 6-8 6-8
*Vivadent Silamat Plus 220V 4000 cpm 8-10 8-10 9-11 9-11 9-11 9-11
*SDI Ultramat 2 4400 cpm 9-12 9-12 9-12 9-12 7-10 7-10
*ESPE CapMix Fixed 4400 cpm 6-7 6-7 6-7 6-7 6-7 6-7
*Torit Capmaster 4200 cpm 13-16 13-16 13-16 13-16 11-15 11-15
The following amalgamators are not recommended for use with Dispersalloy
®
Amalgam in Self-Activating Capsules:
*ESPE Rotamix and *Torit Single Speed Model TRA-18-1
*Not products of DENTSPLY International.
Suggestions for obtaining optimum mix
2.1 The triturated amalgam should be bright and have a plastic consistency. If the amalgam is excessively splashy
and wet looking, INCREASE trituration time or amalgamator speed. Amalgam that appears excessively dry
indicates trituration time or amalgamator speed should be DECREASED.
2.2 When performing adjustments, it is recommended to adjust trituration time in 2 second increments, until
optimum mix is obtained. Greater adjustments may indicate
amalgamator incompatibility or compromised functionality.
Decrease trituration time:
Increase trituration time:
- To lengthen working time - To shorten working time
- If mix is too hot - If mix is too wet
- If mix is too dry
2.3 Properly triturated Dispersalloy
®
Amalgam does not require mulling to produce a smooth plasticity; however
you may mull for 1-2 seconds after removing pestle to
collect amalgam into a single mass.
3. Condensation
3.1 No tool is needed to open the Self-Activating capsule. Just grasp both ends of the capsule, twist, and pull apart.
Turn the opened capsule upside down to drop the amalgam mass into the work area. Dispersalloy
®
Amalgam
is now ready for immediate placement and condensation. A gentle tap may be required to free amalgam from
the capsule. Do not attempt to manually express mercury from the triturated mass prior to placement.
3.2 A plastic wafer and/or plastic mixing pestle may be seen. These have no further function and should be
properly recycled.
0120
3.3 Condense immediately after mix is completed. Use a clean amalgam carrier to transfer increments to the
cavity. Pack each increment into angles and undercuts with small-faced plugger and sufficient pressure to
insure good adaptation. Build the restoration with additional portions, until the cavity is slightly overfilled.
Remove any mercury-rich amalgam from the surface that may develop during condensation.
4. Carving/Burnishing: Carving can begin immediately after condensation. A sharp carver will give best results. The
anatomy should be carved proceeding from the proximal margins towards the center of the restoration. Before the
matrix band is removed, the marginal ridge should be supported by a condenser. After removal of the matrix band,
gingival margins may be smoothed with a curved explorer. Burnishing setting amalgam is recommended to improve
surface smoothness.
5. Polishing: The quality of the Dispersalloy
®
Amalgam restoration will be enhanced by polishing. The amalgam should
be allowed to set 24 to 48 hours before polishing. See selected polishing instrument manufacturer’s directions for use.
9. LOT NUMBER AND EXPIRATION DATE
1. Do not use after expiration date. ISO standard is used: “YYYY/MM”
2. The following numbers should be quoted in all correspondence:
• Reorder number
• Lot number on package
• Expiration date on package
©2008 DENTSPLY International. All rights reserved. Printed in U.S.A.
Manufactured by:
DENTSPLY Caulk
38 West Clarke Avenue
Milford, DE 19963 U.S.A.
Tel.: 1-302-422-4511
www.dentsply.com
Distributed by:
DENTSPLY Canada
161 Vinyl Court
Woodbridge, Ontario
L4L 4A3 Canada DENTSPLY D
E
T
REY
GmbH
De-Trey-Str. 1
78467 Konstanz
Germany
Tel.: 49-7531-583-0
www.dentsply.de
Form #556018 (R 10/2/08)