4
2.1 Warnings
The material contains methacrylates and polymerizable monomers which may be irritating to skin,
eyes and oral mucosa and may cause sensitization by skin contact and allergic contact dermatitis
in susceptible persons.
•
Avoid eye contact
to prevent irritation and possible corneal damage. In case of contact with
eyes, rinse with plenty of water and seek medical attention.
•
Avoid skin contact
to prevent irritation and possible allergic response. In case of contact, red-
dish rashes may be seen on the skin. If contact with skin occurs, remove material with cotton
and alcohol and wash thoroughly with soap and water. In case of skin sensitization or rash,
discontinue use and seek medical attention.
•
Avoid contact with oral soft tissues/mucosa
to prevent inflammation. If accidental contact
occurs, remove material from the tissues. Flush mucosa with plenty of water and expectorate/
evacuate the water. If inflammation of mucosa persists, seek medical attention.
2.2 Precautions
This product is intended to be used only as specifically outlined in these Directions for Use.
Any use of this product inconsistent with these Directions for Use is at the discretion and sole
responsibility of the dental practitioner.
• If refrigerated, allow material to reach room temperature prior to use.
• Contact with saliva, blood and sulcus fluid during application may cause failure of the restoration.
Use adequate isolation such as rubber dam.
• Use protective measures for the dental team and patients such as glasses and rubber dam in
accordance with local best practice.
• Devices marked “single use” on the labeling are intended for single use only. Discard after use.
Do not reuse in other patients in order to prevent cross-contamination.
• The syringes cannot be reprocessed. To prevent syringes from exposure to spatter or spray
of body fluids or contaminated hands it is mandatory that the syringes are handled with clean/
disinfected gloves. Discard syringes if contaminated.
• As additional precautionary measure, syringes may be protected from gross debris but not from
all contamination by applying a protective barrier.
• Use of Compules
®
Tips with the Compules
®
Tips Gun is recommended.
• The Compules
®
Tips Gun is only intended to be used with Dentsply Sirona Compules
®
or
Compula
®
Tips.
• For further information please refer to the Compules
®
Tips Gun Directions for Use.
• The shade guide and the individual shade guide tabs cannot be reprocessed. To prevent the
shade guide and the individual shade guide tabs from exposure to spatter or spray of body fluids
or contaminated hands it is mandatory that the shade guide and the individual shade guide tabs
are handled with clean/disinfected gloves.
• The material should extrude easily. DO NOT USE EXCESSIVE FORCE. Excessive pressure
may cause the Compules
®
Tip to rupture or to eject from the Compules
®
Tips Gun.
• Tightly close syringes immediately after use.
• Interactions:
– Do not use eugenol- or hydrogen peroxide-containing materials in conjunction with this prod-
uct since they may interfere with hardening of the product.
2 Safety notes
Be aware of the following general safety notes and the special safety notes in other chapters of
these Directions for Use.
Safety alert symbol.
• This is the safety alert symbol. It is used to alert you to potential personal injury
hazards.
• Obey all safety messages that follow this symbol to avoid possible injury.
