PRIME & BOND 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT
K960823 · Dentsply Intl. · KLE · Apr 26, 1996 · Dental
Device Facts
| Record ID | K960823 |
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| Device Name | PRIME & BOND 2.0 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 | Apr 26, 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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| Attributes | Therapeutic |
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Intended Use
PRIME & BOND™ 2.0 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-curable dental bonding agent; consists of monomers, adhesion promoter, acetone solvent, photo-initiators, accelerators, and polymerization inhibitors. Applied by clinician to prepared tooth surface; left for 20-30 seconds; air-dried; light-cured for 10 seconds. Used in dental clinics for restorative procedures and repairs. Provides adhesive interface between tooth structure/restorative materials and restorative composites/amalgams/porcelain/metal.
Clinical Evidence
Bench testing only; no clinical data presented. Safety supported by toxicity testing (cytotoxicity and irritation) performed on predicate device K931812.
Technological Characteristics
One-component, light-curable resin bonding agent. Composition: monomers, adhesion promoter, acetone, photo-initiators, accelerators, polymerization inhibitors. Polymerization via visible light energy.
Indications for Use
Indicated for use in direct and indirect dental restorative procedures, adhesive repairs of amalgams, porcelain/metal and composite restorations, 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™ Direct Composite Bonding Agent (K931812)
- Prime & Bond - New Uses (K951864)
Related Devices
- K962348 — PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT · Dentsply Intl. · Jul 18, 1996
- K962515 — KERR ADVANCED ADHESIVE · Kerr Dental Materials Center · Aug 1, 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
- K011908 — OPTIBOND SOLO PLUS 3 · Kerr Dental Materials Center · Sep 6, 2001
Submission Summary (Full Text)
{0}
510(k) SUMMARY
K960823
APR 26 1996
# 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
CONTACT: P. Jeffery Lehn
DATE PREPARED: February 27, 1996
TRADE OR PROPRIETARY NAME: PRIME & BOND™ 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT
COMMON OR USUAL NAME: Bonding agent
CLASSIFICATION NAME: Resin tooth bonding agent 21 CFR, 872.3200
LEGALLY MARKETED DEVICE:
Prime & Bond™ Direct Composite Bonding Agent K931812
Prime & Bond - New Uses K951864
DEVICE DESCRIPTION: PRIME & BOND™ 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT is a one-component, no-mix visible light curable dental bonding agent.
The new bonding agent consists of a mixture of monomers 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™ 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT is applied, left on the surface for 20-30 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.
INTENDED USE: PRIME & BOND™ 2.0 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.
TECHNOLOGICAL CHARACTERISTICS: All of the components of PRIME & BOND™ 2.0 SELF-PRIMING DENTIN/ENAMEL BONDING AGENT have been used in Dentsply legally marketed predicate devices.
In K931812, Prime & Bond™ Direct Composite Bonding Agent was 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 this predicate device, we believe that additional toxicity testing for PRIME & BOND™ 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT is unnecessary.
We believe that the prior use of the PRIME & BOND™ 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT components in predicate devices, the performance data presented, and the results of toxicity testing on predicate devices, support the safety and effectiveness of PRIME & BOND™ 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT for the intended uses.
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