Adverse Reactions; Cleaning And Disinfection - DENTSPLY Esthet X HD Manual Del Usario

ADVERSE REACTIONS

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.
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
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
leaving the rest of the cavity surface free for bonding with Prime&Bond
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
Gel. Attach disposable needle to end of syringe. Needle tip may be bent for
easy access. Gently extrude Caulk
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
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
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 ®
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
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
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
tooth surfaces. This surface should remain fully wet for 20 seconds and may
necessitate additional applications of Prime&Bond
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 ™
1.5 Completion: Place restorative material over the cured Prime&Bond
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 ®
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
surface of the restoration. Immediately air dry for 5 seconds.
2.4.4 Cure Prime&Bond ® NT ™
® Prophylaxis Paste. Wash thoroughly with water
® 34% Tooth Conditioner
® 34% Tooth Conditioner Gel (34%
® NT ™ Light Cured Dental Adhesive. NOTE: The
NT ™ Light Cured Dental Adhesive
® NT ™ Adhesive directly onto a
® NT ™ Adhesive to thoroughly wet all the
® NT ™ Adhesive.
Adhesive for 10 seconds 1 using a curing light.
®
NT ™ Light Cured Dental Adhesive: Apply and light
® NT ™ Adhesive to the internal bonding
Adhesive for 10 seconds 1 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
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
manufacturer's instructions.
3.4 Application of Prime&Bond
cure 1 Prime&Bond
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
® Liner)
When used as a cavity varnish, Prime&Bond
® NT ™ Light
amalgam adhesive.
4.1 Preparation: Finish preparation by removing existing restorations and/or caries.
4.2 Cleaning: Clean preparation and place Dycal
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
Adhesive. If desired, follow Section 1.3.
4.4 Application of Prime&Bond
cure Prime&Bond
1.4.
4.5 Completion: Place and condense amalgam (e.g. Dispersalloy
Alloy) as per manufacturer's directions.
® 34%

CLEANING AND DISINFECTION

To prevent Prime&Bond
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.
DISINFECTION OF RE-USABLE BRUSH HANDLE AND UNIT DOSE
HOLDER
The brush handle or holder, if exposed to spatter or spray of body fluids or that may have
been touched by contaminated hands, or oral tissues, should be disinfected with a hospital-
level disinfectant. Acceptable disinfectants are EPA-registered as tuberculocidal. Iodophors,
sodium hypochlorite (5.25%), chlorine dioxide and dual or synergized quaternaries are
approved disinfectants. Disinfect the brush handle by spraying with or immersing in any
recommended hospital-level disinfectant except neutral glutaraldehyde for the contact time
® NT ™
recommended by the disinfectant manufacturer for optimum results. Some phenolic-based
agents and iodophor-based products may cause surface staining. Agents containing
organic solvents, such as
alcohol, may tend to dissolve the plastic. The disinfectant manufacturer's directions should
be followed properly for optimum results. Water-based disinfectant solutions are preferred.
LOT NUMBER AND EXPIRATION DATE
1. Do not use after expiration date. ISO standard is used: "YYYY/MM"
2. The following numbers should be quoted in all correspondence:
• Reorder Number
• Lot number on syringe/bottle
• Expiration date on syringe/bottle
1 Check curing light for minimum curing output of at least 550 mw/cm2 and a spectral output including 470nm (peak
absorption of the CQ photoinitiator).
NT ™ Adhesive
©2006 DENTSPLY International Inc. All Rights Reserved. Printed in U.S.A.
0120
Manufactured in the
U.S.A by:
DENTSPLY Caulk
38 West Clarke Avenue
Milford, DE 19963
Tel.: 1-302-422-4511
® Silane Coupling Agent to porcelain surfaces to be repaired following
® NT ™ Light Cured Dental Adhesive: Apply and light
® NT ™ Adhesive as described for direct restorations, see Section
® NT ™ Light Cured Adhesive is not an
® Liner if needed, following Sections 1.1
® NT ™ Light Cured Dental Adhesive: Apply and light
® NT ™ Adhesive as described for direct restorations, see Section
® NT ™ Adhesive bottle from exposure to spatter or spray of body
Distributed by: Authorized EU
DENTSPLY Canada Representative:
161 Vinyl Court DENTSPLY DeTrey GmbH
Woodbridge, Ontario De-Trey-Str. 1
L4L 4A3 Canada 78467 Konstanz
Germany
Tel.: 49-7531-583-0
® 34% Tooth
® NT ™
® Dispersed Phase
Swiss Representative:
DENTSPLY DeTrey Sarl
Baar Office
Oberdorfstrasse 11
CH-6342 Baar
Switzerland
Tel.: 41-41-766-2066
Form #534352 (R 5/3/06)