Essix® PLUS™ Plastic
INSTRUCTIONS FOR USE
INTENDED USE:
Essix® PLUS Plastic is thermoformed to fabricate intra-oral appliances such as retainers, aligners for minor tooth movement, and temporary bridges.
INDICATIONS FOR USE:
Mouthguard and aligner materials are indicated for the fabrication of orthodontic and dental appliances such as aligners, bite planes, mouthguards,
nightguards, snoring appliances, splints, retainers, repositioners, and temporary bridges.
PERFORMANCE CHARACTERISTICS AND CLINICAL BENEFITS:
Performance characteristics of orthodontic plastics include a good combination of strength, durability and clarity, resistant to cracking or breaking, easily
removeable from models and effortless to trim.
Clinical benefits of orthodontic treatment may include overall improvement of tooth health and correction of malocclusion.
CONTRAINDICATIONS:
This product is contraindicated for patients with a history of allergic reactions to plastics.
WARNINGS:
Excessive heating time during thermoforming will cause plastic to over sag and potential for injury to operator.
Improper thermoforming of the plastic appliance may cause the appliance to crack/break, resulting in sharp edges, loose pieces and possible aspiration of
pieces.
Report serious incidents that have occurred in relation to the device to device manufacturer and the Competent Authority in Member State of residence,
or other applicable regulatory agency.
PRECAUTIONS:
Patients with a history of allergic reactions to plastics should not use this product.
Do not reuse plastic sheet. Once thermoformed it cannot be reused.
Thermoformed device is for Single Patient Use. Risks of reuse include infection and contamination (i.e. bacterial, viral).
Store plastic sheets in a cool, dry place.
Use within one day of opening foil pouch
.
ADVERSE REACTIONS:
Allergic reactions.
Improper thermoforming of the plastic appliance may cause the appliance to crack/break, resulting in sharp edges, loose pieces and possible aspiration of
pieces.
STEP BY STEP INSTRUCTIONS:
Thermoforming Instructions (for complete instructions, refer to thermoforming equipment manual):
1.
Essix® PLUS Plastic has a protective film on both sides of the sheet. REMOVE FILM FROM BOTH SIDES BEFORE THERMOFORMING.
2.
All models should be trimmed to ¾” high. Full arch models should have the palate trimmed away.
3.
Spray the model with Trim-Rite® Release Agent to prevent the material from sticking to the model.
4.
Place the plastic into the frame of the machine and the model on the base plate.
5.
Scan/Enter the code per thermo-forming machine used. Swing the heating element over the plastic and press the appropriate start button.
*
NOTE
: The heating times below should be used as a reference as heating time may vary depending upon machine. If plastic does not adapt to
model, add heating time until adaptation occurs. If plastic “folds” when thermoformed, reduce heating time until material does not fold.
Thickness
Biostar™ Code
Drufomat
0.88mm (.035”)
133
1:20
1.0mm (.040”)
143
1:25
6.
Move the heating element away from the plastic when the heating and cooling time expires.
7.
Drufomat: hold the element away and press the button on the side to engage the pressure chamber. Biostar: flip the heated plastic over the model.
8.
After the cooling stage, release the pressure per thermo-forming machine used.
9.
Remove the formed tray from the frame of the machine.
10.
Trim and finish the appliance as desired.
SAFE DISPOSAL:
Unused plastic sheets can be recycled.
Used dental appliances may be considered a biohazard. Follow your country-specific laws, directives, standards and guidelines for the disposal of used
devices.
Manufacturer:
Dentsply Sirona Orthodontics Inc.
7290 26th Court East
Sarasota, FL 34243 USA
Emergo Europe
Prinsessegracht 20
2514 AP, The Hague
The Netherlands
Maillefer Instruments
Holding Sàrl
Chemin du verger 3
CH-1338 Ballaigues
MKT-DFU0033-ML Rev. 04
Issued 12-2021
Biostar and Drufomat are not trademarks
of Dentsply Sirona.
www.dentsplysirona.com/ifu
©2021 Dentsply Sirona
ENG
