PRIME & BOND 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT

K960823 · Dentsply Intl. · KLE · Apr 26, 1996 · Dental

Device Facts

• Record ID: K960823
• Device Name: PRIME & BOND 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT
• Applicant: Dentsply Intl.
• Product Code: KLE · Dental
• Decision Date: Apr 26, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2
• 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.

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)

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
[phone]
Fax [phone]
P. J. Lehn Telefax [phone]

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.

000014