← Product Code [KLE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE) · K960823

# PRIME & BOND 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT (K960823)

_Dentsply Intl. · KLE · Apr 26, 1996 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K960823

## Device Facts

- **Applicant:** Dentsply Intl.
- **Product Code:** [KLE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE.md)
- **Decision Date:** Apr 26, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3200
- **Device Class:** Class 2
- **Review Panel:** Dental
- **Attributes:** Therapeutic

## 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.

## Regulatory 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](/device/K931812.md))
- Prime & Bond - New Uses ([K951864](/device/K951864.md))

## Submission Summary (Full Text)

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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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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K960823](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K960823)

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