DENTSPLY Prime&Bond Elect Instrucciones De Uso

Prime&Bond Elect
Universal Dental Adhesive
DIRECTIONS FOR USE – ENGLISH
For dental use only.
USA: Rx only.
1. PRODUCT DESCRIPTION
Prime&Bond Elect ® Universal Dental Adhesive is a universal self-priming dental adhesive
system designed to bond resin based materials to enamel and dentin as well as to metals and
ceramic. Prime&Bond Elect ® Universal Dental Adhesive combines etchant, primer and
adhesive in a one-bottle material. This robust formulation allows the operator to utilize selective
phosphoric acid etching of enamel, phosphoric acid etching of both enamel and dentin, or no
phosphoric acid etching prior to application, ensuring high bond strength and protection
against microleakage.
When mixed with Self Cure Activator, Prime&Bond Elect
designed to be used with DENTSPLY manufactured dual cure/self cure resin cements to bond
all indirect restorations and DENTSPLY manufactured dual cured composite restoratives. When
used with the Amalgam Bonding Accessory Kit, available separately, Prime&Bond Elect
Universal Dental Adhesive also adhesively bonds fresh amalgam to enamel and dentin.
1.1 Delivery forms*
Prime&Bond Elect ® Universal Dental Adhesive is available in:
• 5.0mL tri-laminated bottle
• 0.125mL disposable containers for single patient use
Self Cure Activator is available in:
• 4.5mL tri-laminated bottle
*Some delivery forms may not be available in all countries
1.2 Composition
Prime&Bond Elect ® Adhesive: Mono-, di- and trimethacrylate resins; PENTA (dipentaerythritol
penta acrylate monophosphate); Diketone; Organic phosphine oxide; Stabilizers; Cetylamine
hydrofluoride; Acetone; Water
Self Cure Activator: Mono- and Di-methacrylate Resins; Catalyst; Photoinitiators; Stabilizers;
Acetone; Water
Amalgam Bonding Base and Amalgam Bonding Catalyst: Dimethacrylate resins; Initiators;
Stabilizers
1.3 Indications
Prime&Bond Elect ® Adhesive (visible light cured):
• Direct, light cured composite and compomer restorative
• Indirect restorations; light cured, resin cemented veneers
• Composite, ceramic and amalgam repairs
• Cavity varnish for use with fresh amalgam
Prime&Bond Elect ® Adhesive with Self Cure Activator (dual cure or self cure):
• Direct, dual cure or self cure composite restorations and core build-ups
• Indirect restorations; dual cured and self cured resin cemented inlays, onlays, crown and
bridge retainers
• Dual cured and self cured resin cemented endodontic post cementation
Prime&Bond Elect ® Adhesive with Self Cure Activator and Amalgam Bonding Base & Catalyst
(dual cure or self cure):
• Adhesive bonding of direct amalgam restoration
1.4 Contraindications
• Prime&Bond Elect ® Adhesive is contraindicated for use with patients who have a known
hypersensitivity to methacrylate resins.
• Prime&Bond Elect ® Adhesive is contraindicated for direct application to dental pulp tissue
(direct pulp capping).
1.5 Compatible restoratives/cements
• Prime&Bond Elect ® Adhesive is chemically compatible with conventional methacrylate-based
visible light cured composite restorative and cement materials including DENTSPLY visible
light cured composite and compomer restorative and cement materials.
• Prime&Bond Elect ® Adhesive mixed with Self Cure Activator is chemically compatible with
conventional methacrylate-based dual and self cured composite restorative materials
including DENTSPLY dual and self cured composite restorative and cement materials. (see
complete directions for use of selected restorative/cement material).
2. GENERAL SAFETY NOTES
Be aware of the following general safety notes and the special safety notes in other chapters of
these directions 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.
® Universal Dental Adhesive is
®
®
2.1 Warnings
Prime&Bond Elect ® Adhesive contains polymerizable methacrylates which may be irritating to
skin, eyes and oral mucosa and may cause allergic contact dermatitis in susceptible persons.
Prime&Bond Elect ® Adhesive is acidic and may cause burns.
• Avoid eye contact to prevent irritation and possible corneal damage. In case of contact with
eyes, rinse immediately with plenty of water and seek medical attention.
• Avoid skin contact to prevent irritation and possible allergic response. If contact with skin
occurs, immediately remove material with cotton and wash thoroughly with water and soap.
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
occurs, immediately 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 Directions for Use.
Any use of this product inconsistent with the Directions for Use is at the discretion and is the
sole responsibility of the practitioner.
• 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.
• Contact with saliva and blood during placement may cause failure of the restoration. Use of
rubber dam or adequate isolation is recommended.
• Wear suitable protective eyewear, mask, clothing and gloves. Protective eyewear is
recommended for patients.
• The Prime&Bond Elect ® Adhesive bottles should be tightly closed immediately after use.
• Once Prime&Bond Elect ® Adhesive is mixed with Self Cure Activator, apply immediately onto
prepared surfaces.
• Use only in well ventilated areas. Avoid inhaling vapor.
• Flammable: Prime&Bond Elect ® Adhesive contains acetone. Keep away from sources of
ignition.
• Compared to selectively applying phosphoric acid (selective etching) to enamel, Prime&Bond
Elect ® Adhesive is less effective on unetched, unground, unprepared, or uncut enamel. For
optimal bonding results, the enamel should be beveled and/or phosphoric acid conditioned
before treatment with Prime&Bond Elect
Interactions:
• Eugenol- and hydrogen peroxide containing 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.
• Prime&Bond Elect ® Adhesive is light cured material. Protect from ambient light.
• If mineral-impregnated (e.g., ferric compounds) retraction cords and/or hemostatic solutions
are used in conjunction with adhesive procedures, 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.
• The use of a dual cure adhesive system such as Prime&Bond Elect
can shorten working time of a dual cure resin cement system. This effect should be
investigated in the laboratory prior to clinical use.
• Variable in vitro data exist regarding use of light-cured-only adhesives such as Prime&Bond
Elect ® Adhesive without Self Cure Activator in conjunction with dual cured or self cured resin
restoratives or cements. Chemical/Product incompatibility may adversely affect product
efficacy, leading to premature restoration failure.
2.3. Adverse reactions
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.
2.4 Storage
Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the
product. Keep out of direct sunlight and store in a well ventilated place at refrigerated
temperatures between 2º-8ºC/35º-46ºF. Allow material to reach room temperature prior to use.
Protect from moisture. Do not freeze. Do not use after expiration date.
3. STEP-BY-STEP INSTRUCTIONS
Prime&Bond Elect ® Universal Dental Adhesive offers the operator total flexibility to utilize:
• selective phosphoric acid etching of just enamel,
• phosphoric acid etching of both enamel and dentin,
• or no phosphoric acid etching prior to application
3.1 General procedures
1. Cleaning: Preparation for all adhesive procedures
Clean freshly instrumented enamel and dentin with water spray and then air dry. Clean
uninstrumented enamel and dentin with a rubber cup and pumice or a cleaning paste such
® Adhesive.
® Dual Cured Adhesive