Prime&Bond NT – dental adhesive

Prime&Bond NT

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 NT Adhesive 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 NT 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 NT Adhesive 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

Adverse reaction
1. Product may irritate the eyes and skin. Eye contact: irritation and possible corneal damage. Skin contact: irritation or possible allergic response. Reddish rashes may be seen on the skin. Mucous membranes: inflammation, edema, sloughing. (See Warnings)
2. Product may cause serious health effects if ingested. (See Warnings)
3. Caulk 34% Tooth Conditioning Gel may cause pulpal effects. (See Contraindications and Warnings)
4. Inhalation of vapors may cause varying degrees of damage to the affected tissue and also increased susceptibility to respiratory illness. (See Precautions)
5. The following medical conditions are generally aggravated by exposure: Individuals with pre-existing skin disorders, eye problems or impaired liver, kidney and respiratory functions.

Prime&Bond NT Adhesive – step-by-step instructions for use(LIGHT CURED)

1. DIRECT RESTORATION (Light Cured Composite Resin and Compomers)
1.1 Cleaning: Clean uninstrumented enamel and dentin with a rubber cup and pumice or a cleaning paste such as Nupro Prophylaxis Paste. Wash thoroughly with water spray and air dry. Clean freshly instrumented enamel and dentin with water spray and then air dry.

1.2 Pulp Protection: For direct and indirect pulp capping, cover the dentin close to the pulp (less than 1mm) with a hard setting calcium hydroxide liner (Dycal Liner) leaving the rest of the cavity surface free for bonding with Prime&Bond NT Light Cured Dental Adhesive.

1.3 Tooth Conditioning/Dentin Pretreatment: When used as a bonding agent for composite materials, it is recommended to follow the total etch technique described in 1.3.1: When used as a bonding agent for compomer materials in non-stress bearing situations, acid etching is optional.

1.3.1 Application of Caulk 34% Tooth Conditioner Gel: After application of rubber dam or other suitable isolation technique, apply Caulk 34% Tooth Conditioner Gel. Attach disposable needle to end of syringe. Needle tip may be bent for easy access. Gently extrude Caulk 34% Tooth Conditioner Gel (34% phosphoric acid) to the cavity surfaces starting at the enamel margins. For best results, condition enamel for at least 15 seconds and dentin for 15 seconds or less. Alternatively the conventional Enamel Etch Technique can be followed. In this case, the enamel margins only are treated with Caulk 34% Tooth Conditioner Gel for at least 15 seconds.

1.3.2 Rinsing and Blot Drying: Remove gel with aspirator tube and/or vigorous water spray and rinse conditioned areas thoroughly for at least 10 seconds. Blot dry conditioned areas with a moist cotton pellet. Proceed immediately to application of Prime&Bond NT Light Cured Dental Adhesive. NOTE: The goal of blot drying is to provide the correct amount of “wetness” on the tooth surface by removing all excess moisture and yet avoiding desiccating the dentin. Do not rub the tooth surface when blot drying. Dentin should be blotted until there is no pooling of water, leaving a moist, glistening surface. Once the surfaces have been properly treated, they must be kept uncontaminated. If salivary contamination occurs, repeat procedure beginning at Step 1.1.

1.4 Application of Prime&Bond NT Light Cured Dental Adhesive

1.4.1  Unit Dose Container: Grasp container at each end, or insert into holder, placing thumb along center score. Firmly apply pressure until container separates. Holder may be placed on the tabletop or held between fingers for convenience. Insert disposable applicator into opening to saturate applicator tip. Conventional Bottle: Dispense Prime&Bond NT Adhesive directly onto a clean disposable brush provided, making sure that the bottle does not come in direct contact with the brush, or place 2-3 drops of Prime&Bond NT Adhesive into a clean well. Replace cap promptly.

1.4.2  Using the disposable brush or applicator tip supplied, immediately apply generous amounts of Prime&Bond NT Adhesive to thoroughly wet all the tooth surfaces. This surface should remain fully wet for 20 seconds and may necessitate additional applications of Prime&Bond NT Adhesive.

1.4.3  Remove excess solvent by gently drying with clean, dry air from a dental syringe for at least 5 seconds. Recommended technique is to begin drying/evaporation with the syringe approximately 4-6 inches (10-15cm) away from the surface, gradually bringing the source to within 0.5 inches (10mm) of the surface over 5-10 seconds. Surface should have a uniform glossy appearance. If not, repeat application and air dry. Surface should not show areas of excessive adhesive thickness or pooling. Repeat air drying/evaporation outlined above if necessary.

1.4.4  Cure Prime&Bond NT Adhesive for 10 seconds1 using a curing light.

1.5 Completion: Place restorative material over the cured Prime&Bond NT Adhesive as per restorative material manufacturer’s directions.

2. VENEER CEMENTATION (Light Cured Resin Cement)
2.1 Cleaning: See Section 1.1

2.2 Tooth Conditioning/Dentin pretreatment: See Section 1.3
2.3 Application of Prime&Bond NT Light Cured Dental Adhesive: Apply and light cure Prime&Bond NT Adhesive as described for direct restorations, see Section 1.4.

2.4 Preparation of restoration

2.4.1  Treat bonding surface of restoration according to manufacturer’s or dental laboratory’s instructions, i.e. etching or mechanical roughening.

2.4.2  Apply Calibra Silane Coupling Agent (available separately) to ceramic or porcelain restoration following manufacturer’s instructions.

2.4.3  Apply a single coat of Prime&Bond NT Adhesive to the internal bonding surface of the restoration. Immediately air dry for 5 seconds.

2.4.4  Cure Prime&Bond NT Adhesive for 10 seconds1 using a curing light

2.5 Cementation: Prepare and apply light-cured resin cement according to manufacturer’s instructions.

3. COMPOSITE, CERAMIC AND AMALGAM REPAIRS (Light Cured Composite Resin and Compomers)
3.1 Preparation, Cleaning: Roughen the fractured surface as much as possible with a diamond bur. Create where possible. For best results, sandblast the area to be repaired with an intraoral microetcher (50µ alumina). Rubber dam is recommended with high speed evacuation. Rinse microetched areas for 15-20 seconds with water. Air dry. NOTE: Bevel porcelain margins before etching.

3.2 Tooth Conditioning/Dentin Pretreatment: Etch tooth with Caulk 34% Tooth Conditioner Gel as outlined in Section 1.3. Etch ceramic restoration repair area with hydrofluoric acid according to manufacturer’s instructions.

3.3 Treatment of the Restoration: Rinse with water for 10 seconds. Air dry. NOTE: Apply Calibra Silane Coupling Agent to porcelain surfaces to be repaired following manufacturer’s instructions.

3.4 Application of Prime&Bond NT Light Cured Dental Adhesive: Apply and light cure1 Prime&Bond NT Adhesive as described for direct restorations, see Section 1.4.

3.5 Completion: Complete repair with placement and curing of desired shade(s) of light cured composite restorative following manufacturer’s directions.

4. CAVITY VARNISH FOR USE WITH FRESH AMALGAM
When used as a cavity varnish, Prime&Bond NT Light Cured Adhesive is not an amalgam adhesive.

4.1 Preparation: Finish preparation by removing existing restorations and/or caries.

4.2 Cleaning: Clean preparation and place Dycal Liner if needed, following Sections 1.1 and 1.2.

4.3 Tooth Conditioning/Dentin Pretreatment: Rinse and carefully air-dry cavity preparation, but do not desiccate exposed dentin. NOTE: Acid etching of prepared cavity (enamel or enamel/dentin) is optional prior to placement of Prime&Bond NT Adhesive. If desired, follow Section 1.3.

4.4 Application of Prime&Bond NT Light Cured Dental Adhesive: Apply and light cure Prime&Bond NT Adhesive as described for direct restorations, see Section 1.4.

4.5 Completion: Place and condense amalgam (e.g. Dispersalloy Dispersed Phase Alloy) as per manufacturer’s directions.

Cleaning and disinfection
To prevent Prime&Bond NT Adhesive bottle from exposure to spatter or spray of body fluids or contaminated hands, or oral tissues, use of a protective barrier is recommended to avoid package contamination. Repeated disinfection may damage label. Do not attempt to clean, disinfect or re-use applicator brush or unit dose container. Properly dispose used brushes and containers. The re-usable brush handle may be cleaned by scrubbing with hot water and soap or detergent. Do not autoclave brush handle or unit dose holder. Disinfect as outlined below.

Prime & Bond NT Package:

Introductory Kit
• 1 Bottle Prime & Bond NT (4.5mL)
• 40 Disposable Brush Tips
• 1 Brush Handle
• 1 Dispensing Well

Refill Package
• 2 Bottles Prime & Bond NT (4.5mL each)

Economy Package
• 3 Bottles Prime & Bond NT (4.5mL each)
• 120 Disposable Brush Tips
• 3 Brush Handles
• 2 Syringes Caulk® 34% Tooth Conditioner Gel (3mL each)
• 1 Dispensing Well

Unit Dose Package
• 80 Unit Doses
• 4 Holders
• 100 Flocked Applicator Tips

Flocked Applicator Tips
• 50 Flocked Applicator Tips

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