DENTSPLY Esthet X HD Manual Del Usario página 19

Prime&Bond
Light Cured Dental Adhesive
DIRECTIONS FOR USE – ENGLISH
Prime&Bond ® NT ™ Adhesive is a light cure self-priming dental adhesive designed to bond
light cured composite and compomer materials to enamel and dentin as well as to metals
and ceramic. Prime&Bond ® NT ™ Adhesive combines primer and adhesive in a single
container. The reduction of components and treatment steps simplifies use, maintaining
superior bond strengths and protection against microleakage. Prime&Bond
is available in a 4.5 ml tri-laminated bottle and in pre-dosed, 0.125 ml disposable containers
for single patient use. For routine dual cure procedures, please see the Prime&Bond
Dual Cure Universal Dental Adhesive System instructions that include the Prime&Bond
NT ™ Adhesive and Self Cure Activator components.
Caulk ® 34% Tooth Conditioner Gel is included in both the Prime&Bond
Economy Kit.
Caution: U.S. federal law restricts this device to sale by or on the order of a dentist.
COMPOSITION
Prime&Bond ® NT ™ Adhesive:
Di- and Trimethacrylate resins; PENTA (dipentaerythritol penta acrylate monophosphate);
Photoinitiators; Stabilizers; Nanofillers - Amorphous Silicone Dioxide Cetylamine
hydrofluoride; Acetone
Caulk ® 34% Tooth Conditioner Gel (See complete directions for use enclosed):
Water; 34% Phosphoric acid; Silicon Dioxide; Surfactants; Blue Colorant
INDICATIONS
1. Direct, light cured composite and compomer restorations.
2. Indirect Restorations; light cured, resin cemented veneers.
3. Composite, ceramic and amalgam repairs.
4. Cavity varnish for use with fresh amalgam.
CONTRAINDICATIONS
1. Prime&Bond ® NT ™ Adhesive is contraindicated for use with patients who have a history
of severe allergic reaction to methacrylate resins or any of the components
2. Prime&Bond ® NT ™ Adhesive is contraindicated for direct application to dental pulp tissue
(direct pulp capping).
3. Caulk ® 34% Tooth Conditioner is contraindicated for use on dental pulp tissue.
WARNINGS
1. Caulk ® 34% Tooth Conditioning Gel contains phosphoric acid, which may cause burns.
Avoid contact with oral tissues, eyes and skin. Do not take internally.
Eye Contact: Tooth Conditioning Gel contains phosphoric acid, which may cause burns
or may be irritating to eyes. Before using this product wear protective glasses as well as
covering the patient's eyes to protect from squirting the material inadvertently. In case of
accidental contact with eyes, rinse eyes immediately with plenty of water and seek
medical attention.
Skin Contact: Tooth Conditioning Gel contains phosphoric acid, which can cause burns
or skin sensitization in susceptible individuals. 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, seek
medical attention immediately.
Oral Mucosa Contact: Avoid contact with oral soft tissues. If accidental contact occurs,
flush mucosa with plenty of water and expectorate water. If sensitization of mucosa
persists, seek medical attention immediately.
Ingestion: Do not swallow or take internally. If accidental swallowing occurs, drink lots of
water. If nausea or illness develop, seek medical attention immediately. Contact regional
Poison Control Center immediately.
2. Prime&Bond ® NT ™ Adhesive contains polymerizable methacrylate monomers. Avoid
prolonged or repeated contact with skin (allergic contact dermatitis), oral soft tissues, and
eyes. Avoid prolonged inhalation. Do not take internally.
Eye contact: Prime&Bond ® NT ™ Adhesive contains methacrylates which may be irritating
to eyes. Before using this product wear protective glasses as well as covering the
patient's eyes to protect from splashing material. In case of contact with eyes, rinse
immediately with plenty of water and seek medical attention.
Skin contact: Prime&Bond ® NT ™ Adhesive contains polymerizable monomers which can
cause skin sensitization (allergic contact dermatitis) in susceptible individuals. If contact
with skin occurs immediately wipe off thoroughly with cotton and alcohol and then wash
well with soap and water after contact. If skin rash and sensitization or other allergic
reaction occurs discontinue use and seek medical attention.
Oral mucosa contact: Avoid contact with oral soft tissues. If accidental contact occurs,
® T ™
flush mucosa with plenty of water and expectorate water. If sensitization of mucosa
persists, seek medical attention immediately.
Ingestion: Do not swallow or take internally. If accidental swallowing occurs, drink lots of
water. If nausea or illness develop, seek medical attention immediately. Contact regional
® NT ™ Adhesive Poison Control Center if necessary.
3. Prime&Bond
® NT ™ oxygen or artificial respiration if necessary.
® 4. Caulk ®
EXCESSIVE FORCE. Excessive pressure may result in unanticipated extrusion of the
material.
® NT ™ Adhesive 5. Caulk ®
of severe allergic reaction to any of the components.
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 and gloves. Protective eyewear is
recommended for patients.
3. Eugenol-containing dental materials should not be used in conjunction with this product
because they may interfere with hardening and cause softening of the polymeric
components of the material.
4. Insufficient data exist to support the use of desensitizing agents and/or cavity cleansing
agents with Prime&Bond
prophylaxis paste with a rubber cup. (See Step-by-Step Instructions)
5. Contact with saliva, blood and/or some astringent solutions during adhesive procedures
may cause failure of the restoration. Use of a rubber dam or adequate isolation is
recommended.
6. Exercise caution if mineral-impregnated (e.g., ferric compounds) retraction cords and/or
hemostatic solutions are used in conjunction with adhesive procedures. In vitro studies
have suggested compromised adhesive bond strength to enamel and dentin
contaminated with hemostatic agents. Marginal seal may be adversely affected, allowing
microleakage, subsurface staining and/or restoration failure. If gingival retraction is
necessary, use of plain, non-impregnated cord is recommended.
7. In vitro studies have shown a relationship between adhesive performance and air-
thinning/drying/solvent evaporation techniques. Improper over-thinning or under-
evaporating may compromise bond strength, leading to microleakage, post-operative
sensitivity and/or restoration failure. (See Step-by-Step Instructions)
8. Replace original cap of Caulk
evaporation. Discard dispensing tip after use, as dispensing tips may clog if gel is
allowed to dry inside.
9. DENTSPLY Caulk supplies the appropriate dispensing tip for the Tooth Conditioning Gel.
This tip is the only tip that should be utilized for placement of the gel.
10. The Prime&Bond
11. Prime&Bond
has been placed in mixing well or protect from ambient light. The components are cured
by visible light.
12. Use only in well ventilated areas.
13. Flammable: Prime&Bond
ignition.
14. Single dose containers are intended for single use only, and should be discarded after
use. Do not re-seal or re-use.
15. The efficacy of Caulk
restorations has not been demonstrated.
16. Variable in-vitro data exist regarding use of light-cured-only adhesives such as
Prime&Bond
or self-cured resins such as Calibra
Releasing Dual Cure Core Build-Up Material in limited or no light curing applications.
Chemical/Product incompatibility may adversely affect product efficacy, leading to
premature restoration failure.
17. Storage and Shelf Life: Prime&Bond
sunlight and stored in a well ventilated place at room temperature not exceeding
25ºC/77ºF. Refrigerated storage is not required, but is acceptable when not in use.
Allow material to reach room temperature prior to use.
Caulk
syringe with dispensing tip in place, as this may harden the material making extrusion
difficult (see Warnings). Not to be stored at temperature exceeding 25°C/77ºF. Protect
from moisture. Do not freeze. Do not use after expiration date.
® NT ™ Adhesive contains acetone. Do not breathe vapor. Inhalation: Give
34% Tooth conditioning Gel in syringes should extrude easily: DO NOT USE
34% Tooth Conditioning Gel should not be used with patients who have a history
® NT ™ Adhesive. Recommended pre-treatment is pumice or
® 34% Tooth Conditioning Gel tightly after each use to avoid
® NT ™ Adhesive bottle should be tightly closed immediately after use.
® NT ™ Adhesive is light-cured material. Proceed immediately once material
® NT ™ Adhesive contains acetone. Keep away from sources of
® 34% Tooth Conditioning Gel as an etchant/cleanser of indirect
® NT ™ Adhesive without Self Cure Activator in conjunction with dual-cured
® Esthetic Resin Cement and FluoroCore
® NT ™
® 34% Tooth Conditioning Gel: Store syringe with original cap only. Do not store
® 2 Fluoride-
Adhesive should be kept out of direct