DENTSPLY Prime&Bond elect Mode D'emploi

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 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 Adhesive is 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 Adhesive also adhesively bonds
fresh amalgam to enamel and dentin.
*NOTE: Calibra Ceram Adhesive Resin Cement may be used following application of
®
Prime&Bond elect Adhesive without the use of Self Cure Activator, additionally
allowing operator's choice of pre-cementation adhesive curing options (see complete
Directions for Use).
1.1 Delivery forms
(Some delivery forms may not be available in all countries)
Prime&Bond elect Adhesive is available in: 5.0mL tri-laminated bottle; 0.125mL disposable
Self Cure Activator is available in: 4.5mL tri-laminated bottle
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;
1.3 Indications
1. Prime&Bond elect Adhesive (visible light cured):
• Direct, light cured composite and compomer restorations
• Indirect restorations; light cured, resin cemented veneers
• Indirect restorations; Calibra Ceram Cement (dual cure or self cure) cemented inlays,
onlays, crown and bridge retainers
• Composite, ceramic and amalgam repairs
• Cavity varnish for use with fresh amalgam
2. Prime&Bond elect Adhesive (without Self Cure Activator or adhesive curing):
• Indirect restorations; Calibra Ceram Cement (dual cure or self cure) cemented endodontic
posts with total etch/etch & rinse technique
3. Prime&Bond elect Adhesive mixed 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
4. Prime&Bond elect Adhesive mixed with Self Cure Activator and Amalgam Bonding Base &
Catalyst:
• 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 is chemically compatible with Calibra Ceram Cement (dual cure
or self cure).
• 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).
containers for single patient use
Stabilizers
®
2. GENER L S FETY 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.
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.
• The bottles cannot be reprocessed. To prevent bottles from exposure to spatter or spray of
body fluids or contaminated hands it is mandatory that the bottle is handled offside the
dental unit with clean/disinfected gloves. During treatment clinicians with patient contact
should not handle bottles.
• 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/etch & rinse) 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 Adhesive.
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 Adhesive mixed with Self
Cure Activator 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 most
resin restoratives or cements. Chemical/Product incompatibility may adversely affect product
efficacy, leading to premature restoration failure.
*NOTE: Calibra Ceram Cement may be used following application of Prime&Bond elect Adhesive without the
use of Self Cure Activator.
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.
* dual cured or self cured