KERR ADVANCED ADHESIVE

K962515 · Kerr Dental Materials Center · KLE · Aug 1, 1996 · Dental

Device Facts

• Record ID: K962515
• Device Name: KERR ADVANCED ADHESIVE
• Applicant: Kerr Dental Materials Center
• Product Code: KLE · Dental
• Decision Date: Aug 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

Kerr Advanced Adhesive is an all purpose dental adhesive consisting of a visible light curable methacrylate resin based mixture of monomers capable of forming both chemical and mechanical adhesive bonds to both natural tooth structures ( enamel and dentin ) and to commonly used restorative materials ( composite resins, porcelain and metals ). It is supplied as a one bottle, single step dental adhesive that is simple to use and produces fast, strong adhesion suitable for all commonly used restorative techniques.

Device Story

One-bottle, single-step dental adhesive; visible light-curable methacrylate resin monomer mixture. Applied by clinician to tooth structure (enamel/dentin) and restorative materials (composite, porcelain, metal). Organic solvent facilitates flow into micro-fissures; solvent evaporation leaves thin resin layer for chemical/mechanical bonding interface. Used in dental clinics for restorative procedures. Benefits include simplified application and strong adhesion.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993: Ames Mutagenicity Assay, Kligman Maximization Study, Cytotoxicity Study (MEM Elution Method USP 23), and Implantation Test. Effectiveness demonstrated via comparative bench testing against predicate devices.

Technological Characteristics

Visible light-curable methacrylate resin monomer mixture; organic solvent-based. One-bottle delivery system. Biocompatibility testing per ISO 10993.

Indications for Use

Indicated for use as a dental adhesive to bond restorative materials, including composite resins, porcelain, and metals, to natural tooth structures (enamel and dentin).

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
• One-Step
• Tenure QUIK

Submission Summary (Full Text)

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K962515

AUG - 1 1996

Page 1 of 1

# 510 ( k ) Summary

## Statement of Safety and Effectiveness

## Kerr Advanced Adhesive

Kerr Advanced Adhesive is an all purpose dental adhesive consisting of a visible light curable methacrylate resin based mixture of monomers capable of forming both chemical and mechanical adhesive bonds to both natural tooth structures ( enamel and dentin ) and to commonly used restorative materials ( composite resins, porcelain and metals ). It is supplied as a one bottle, single step dental adhesive that is simple to use and produces fast, strong adhesion suitable for all commonly used restorative techniques. The organic solvent component allows the application of the adhesive to flow into micro-fissures of the substrate smoothly and when the fast evaporating solvent is removed a thin resin layer remains to form a tight bonding interface between tooth and restorative material.

The safety of Kerr Advanced Adhesive has been demonstrated by subjecting cured samples of the adhesive to various types of biocompatibility tests as recommended in the ISO 10993 biocompatibility guidance standard. These tests were conducted by an independent laboratory which specializes in safety and toxicity evaluation. The tests include:

1. Ames Mutagenicity Assay
2. Kligman Maximization Study ( Allergenic Potential Evaluation )
3. Cytotoxicity Study ( MEM Elution Method USP 23 )
4. Implantation Test ( Tissue Sensitization )

Effectiveness or suitability to the intended purpose of Kerr Advanced Adhesive has been demonstrated by a combination of in-house testing and side by side test comparisons to a predicate device currently on the market. Results of this bench testing indicates that Kerr Advanced Adhesive performs as well or better than PRIME & BOND, One-Step, and Tenure QUIK, three predicate devices currently on the market and being represented as one step all-purpose dental adhesives