DENTSPLY XENO IV Instrucciones De Uso

Xeno IV
®
One Component Light Cured Self-Etching Dental Adhesive
DIRECTIONS FOR USE – ENGLISH
Xeno ® IV One Component Light Cured Self-Etching Dental Adhesive is a one component light
cured self-etching and self-priming dental adhesive designed to bond composite and
compomer materials to enamel and dentin as well as to repair metals and ceramic. Xeno
One Component Light Cured Self-Etching Dental Adhesive combines etchant, primer and
adhesive in a single bottle. The reduction of components and treatment steps simplifies use,
maintaining superior bond strengths and protection against microleakage.
Caution: U.S. federal law restricts this device to sale by or on the order of a dentist.
COMPOSITION
Mono-, Di- and Trimethacrylate resins; PENTA (dipentaerythritol penta acrylate
monophosphate); Photoinitiators; Stabilizers; Cetylamine hydrofluoride; Acetone; Water
INDICATIONS
1. Direct, light cured composite and compomer restorations.
2. Composite, ceramic and amalgam repairs.
3. Cavity varnish for use with fresh amalgam.
CONTRAINDICATIONS
1. Xeno ® IV Adhesive is contraindicated for use with patients who have a history of severe
allergic reaction to methacrylate resins.
2. Xeno ® IV Adhesive is contraindicated for direct application to dental pulp tissue (direct pulp
capping).
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.
WARNINGS
1. Xeno ® IV Adhesive is acidic in nature and contains polymerizable acrylate and 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: Xeno ® IV 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: Xeno ® IV Adhesive is acidic and contains polymerizable monomers which can
cause skin irritation or 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,
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 if necessary.
2. Xeno ® IV Adhesive contains acetone. Do not breathe vapor. Inhalation: Give oxygen or
artificial respiration if necessary.
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. 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.
4. 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.
5. Insufficient data exist to support the use with cementation of indirect restorations.
6. Insufficient data exist to support the use of desensitizing agents and/or cavity cleansing
agents with Xeno ® IV Adhesive. Recommended pre-treatment is pumice or prophylaxis paste
with a rubber cup. (See Step-by-Step Instructions)
7. Insufficient data exist to support the use of Xeno
IV Dual Cure Self-Etching Dental Adhesive in conjunction with phosphoric acid or the use on
phosphoric acid conditioned (etched) enamel and/or dentin.
8. Xeno ® IV Adhesive is less effective on unground, unprepared, or uncut enamel. Overfilling of
the restorative onto unground, or uncut enamel could cause marginal discoloration. For
optimal bonding results, the enamel in Class III, IV, V's and diastema closures should be
beveled before treatment with the Xeno
® IV Light Cured Dental Adhesive and Xeno
® IV Adhesive.
9. Contact with saliva, blood and/or some astringent solutions during adhesive procedures
may cause failure of the restoration. Use of rubber dam or adequate isolation is
® IV recommended.
10. 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.
11. 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)
12. The Xeno ® IV Adhesive bottle should be tightly closed immediately after use.
13. Xeno ® IV Adhesive is light-cured material. Proceed immediately once material has been
placed in mixing well or protect from ambient light. The components are cured by visible
light.
14. Use only in well ventilated areas.
15. Flammable: Xeno ® IV Adhesive contains acetone. Keep away from sources of ignition.
16. Variable in-vitro data exist regarding use of light-cured-only adhesives such as Xeno
One Component Light Cured Self Etching Dental Adhesive without Self Cure Activator in
conjunction with indirect restorations and/or dual cured or self cured resins such as
Calibra ® Esthetic Resin Cement and FluoroCore
core build-up material. Chemical/Product incompatibility may adversely affect product
efficacy, leading to premature restoration failure.
17. Storage and Shelf Life: Xeno
kept out of direct sunlight and stored in a well ventilated place at refrigerated temperature
between 2°C/35ºF and 8°C/46ºF when not in use. Allow material to reach room temperature
prior to use. Protect from moisture. Do not freeze. Do not use after expiration date.
ADVERSE REACTIONS
1. Product may irritate the eyes, skin and mucous membranes. 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. Inhalation of vapors may cause varying degrees of damage to the affected tissue and also
increased susceptibility to respiratory illness. (See Precautions)
4. 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: For optimal adhesion, always instrument (bevel) all enamel and/or margins
(carbide or diamond bur) prior to application. Clean freshly instrumented enamel and
dentin with water spray and then air dry. Clean uninstrumented dentin with a rubber cup
and pumice or a cleaning paste such as NUPRO
with water spray and blot or lightly air dry. Do not desiccate dentin.
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
of the cavity surface free for bonding with Xeno
• Once the surfaces have been properly treated, they must be kept uncontaminated. If
salivary contamination occurs, repeat procedure beginning at step 1.1.
1.3 Application of Xeno
1.3.1 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: Place 2-3 drops of Xeno
Replace cap promptly.
1.3.2 Using the disposable microbrush applicator tip supplied, immediately apply and
scrub surfaces with generous amounts of Xeno
the tooth surfaces for 15 seconds. For larger restorations, i.e. MOD in molars, a
scrubbing time of 20 seconds is recommended.
1.3.3 Apply a second application of Xeno
scrubbing for 15 seconds (20 seconds for larger restorations).
®
1.3.4 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.
® 2 Fluoride-Releasing Dual Cure composite
® IV Adhesive should be stored with the original cap only,
® Prophylaxis Paste. Wash thoroughly
® IV Adhesive.
® IV Adhesive
® IV Adhesive into a clean well.
® IV Adhesive to thoroughly wet all
® IV Adhesive with the microbrush as above,
® IV
® Liner) leaving the rest