PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT
K962348 · Dentsply Intl. · KLE · Jul 18, 1996 · Dental
Device Facts
| Record ID | K962348 |
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| Device Name | PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT |
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| Applicant | Dentsply Intl. |
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| Product Code | KLE · Dental |
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| Decision Date | Jul 18, 1996 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 872.3200 |
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| Device Class | Class 2 |
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Intended Use
PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT is a self-priming bonding agent for use in direct and indirect restorative procedures, for adhesive repairs of amalgams, porcelain/metal and composite, and for an adhesive cavity varnish.
Device Story
One-component, no-mix, visible light-curing dental bonding agent; releases fluoride. Applied to prepared tooth surface; left for 20 seconds; air-dried; light-cured for 10 seconds. Used by dentists in clinical settings for restorative procedures and repairs. Enhances bond strength between tooth structure and restorative materials; provides marginal integrity; reduces post-operative hypersensitivity.
Clinical Evidence
Bench testing only. Performance data provided for direct/indirect composite bond strength and microleakage values, demonstrating comparability to predicate device K960823.
Technological Characteristics
One-component, light-cured resin bonding agent. Composition: monomers, fluoride, adhesion promoter, acetone solvent, photo-initiators, accelerators, polymerization inhibitors. Polymerization via visible light energy. Shelf-stable formulation.
Indications for Use
Indicated for use in direct and indirect dental restorative procedures, adhesive repairs of amalgams, porcelain/metal, and composite, and as an adhesive cavity varnish.
Regulatory Classification
Identification
A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.
Predicate Devices
- Prime & Bond™ 2.0 Multipurpose Dentin/Enamel Bonding Agent (K960823)
- Fluoride-PSA Prime/Adhesive (K941572)
- Prime & Bond Direct Composite Bonding Agent (K931812)
Related Devices
- K960823 — PRIME & BOND 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT · Dentsply Intl. · Apr 26, 1996
- K260682 — Bond-PR Universal Adhesive · Premier Dental Products Company · Mar 3, 2026
- K111980 — CLEARFIL TRI-S BOND PLUS · Kuraray America, Inc. · Oct 14, 2011
- K111975 — CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK · Kuraray Medical, Inc. · Oct 14, 2011
- K962515 — KERR ADVANCED ADHESIVE · Kerr Dental Materials Center · Aug 1, 1996
Submission Summary (Full Text)
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K960348
510(k) SUMMARY
DENTSPLY
NAME & ADDRESS:
DENTSPLY International
570 West College Avenue
P.O. Box 872
York, PA 17405-0872
(717) 845-7511
Fax (717) 854-2343
P. J. Lehn Telefax (717) 849-4343
JUL 18 1996
CONTACT: P. Jeffery Lehn
DATE PREPARED: June 17, 1996
TRADE NAME: PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT
COMMON OR USUAL NAME: Bonding agent
CLASSIFICATION NAME: Resin tooth bonding agent 21 CFR, 872.3200
PREDICATE DEVICES:
Prime & Bond™ 2.0 Multipurpose Dentin/Enamel Bonding Agent K960823
Fluoride-PSA Prime/Adhesive K941572
Prime & Bond Direct Composite Bonding Agent K931812
DEVICE DESCRIPTION: PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT is a one-component, no-mix, visible light curing dental bonding agent that releases fluoride.
The new bonding agent consists of a mixture of monomers, fluoride, and an adhesion promoter in an acetone solution. Additionally, the mixture contains photo-initiators, accelerators and polymerization inhibitors which allow for a shelf stable material that can be polymerized using visible light energy.
Once the tooth to be restored has been prepared, PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT is applied, left on the surface for 20 seconds, air dried, and then light cured for 10 seconds. A second application may be applied for direct restorative procedures, but this is not required for indirect procedures.
PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT and Prime & Bond™ 2.0 Multipurpose Dentin/Enamel Bonding Agent (K960823) are comparable in direct composite bond strength (dentin, enamel, adhesive repair), indirect composite bond strength (metal appliances, inlays, onlays, veneers), and microleakage values. PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT has a high degree of marginal integrity and a reduced incidence of post operative hypersensitivity.
INTENDED USE: PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT is a self-priming bonding agent for use in direct and indirect restorative procedures, for adhesive repairs of amalgams, porcelain/metal and composite, and for an adhesive cavity varnish. The intended uses of PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT are identical to the intended uses of Prime & Bond™ 2.0 Multipurpose Dentin/Enamel Bonding Agent (K960823).
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510(k) SUMMARY (cont'd.)
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TRADE NAME: PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT
TECHNOLOGICAL CHARACTERISTICS: All of the components of PRIME & BOND™ 2.1 SELF-PRIMING DENTIN/ENAMEL BONDING AGENT have been used in the DENTSPLY predicate devices, Prime & Bond™ 2.0 Multipurpose Dentin/Enamel Bonding Agent (K960823) and Fluoride-PSA Prime/Adhesive (K941572). These devices were evaluated for cytotoxicity and for irritation and found to be non-cytotoxic and a non-irritant. Due to the similarity of the new formulation to the primary predicate device (K960823), we believe that additional toxicity testing for PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT is unnecessary.
We believe that the prior use of the PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT components in predicate devices, the near identical formulation to the predicate device, the performance data and fluoride release data presented, and the results of toxicity testing on predicate devices, support the safety and effectiveness of PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT for the intended uses.
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