Instructions For Use; Safety Notes - Dentsply Sirona Dyract eXtra Instructions For Use Manual

The caries preventing restorative
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  • ENGLISH, page 3
1.3 Indications
• Direct restorations of all cavity classes in anterior and posterior teeth. Cavity width must be less
than 2/3 of the intercuspal distance.
1.4 Contraindications
• Use with patients who have a history of severe allergic reaction to methacrylate resins or any of
the other components.
• Class I and II cavities the width of which exceeds 2/3 of the intercuspal distance.
• Core build-up.
1.5 Compatible adhesives
The material is to be used following application of a compatible methacrylate-based dentin/enamel
adhesive such as Dentsply Sirona adhesives designed for use with visible light cured composite
restoratives.
Xeno
, self etching adhesives and Prime&Bond
®
mended.
2

Safety notes

Be aware of the following general safety notes and the special safety notes in other chapters of
these Instructions 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.
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 oc-
curs, remove material from the tissues. Flush mucosa with plenty of water after the restoration is
completed 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 Instructions for Use.
Any use of this product inconsistent with these Instructions for Use is at the discretion and sole
responsibility of the dental practitioner.
• Use protective measures for the dental team and patients such as glasses and rubber dam in
accordance with local best practice.
• The Compules
application from exposure to spatter or spray of body fluids or contaminated hands it is manda-
tory that the devices are handled offside the dental unit with clean/disinfected gloves. Discard
devices if contaminated.
Tips cannot be reprocessed. To prevent Compules
®
NT, etch and rinse adhesive are especially recom-
®
Tips when used for indirect
®
3

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