3M DENT SYSTEM

K962785 · 3M Company · KLE · Aug 12, 1996 · Dental

Device Facts

• Record ID: K962785
• Device Name: 3M DENT SYSTEM
• Applicant: 3M Company
• Product Code: KLE · Dental
• Decision Date: Aug 12, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 3M™ Dent System is intended to be used as a 21 CFR 872.3200 resin tooth bonding agent.

Device Story

3M™ Dent System is a resin-based dental adhesive system; used by dental practitioners for tooth bonding. System utilizes phosphoric acid etchant and methacrylate resin; polymerizes upon exposure to visible light from dental light curing unit. Resin functions as both primer and adhesive. Applied in clinical dental settings to bond restorative materials to dentin and enamel. Benefits include improved adhesion and reduced microleakage in dental restorations.

Clinical Evidence

Bench testing only. Performance data includes bond strength to dentin, enamel, and dental materials; dentin permeability; and microleakage. Biological safety assessment conducted per ISO-10993.

Technological Characteristics

Resin-based dental adhesive system. Components: phosphoric acid etchant and methacrylate resin. Polymerization via visible light curing unit. Complies with ISO-10993 for biological safety.

Indications for Use

Indicated for use as a resin tooth bonding agent for dental applications.

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

• 3M™ Scotchbond™ Multi-Purpose Plus Dental Adhesive System (K942493)
• Prime & Bond™ Direct Composite Bonding Agent (K951864)
• One Step™ Universal Dental Adhesive System (K# unknown)

Submission Summary (Full Text)

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St. Paul, MN 55144-1000
612 733 3149

AUG 12 1996
K962785

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

Name: Scott T. Erickson
Regulatory Affairs Specialist

Address: 3M Dental Products Laboratory
3M Center, Building 260-2B-09
St. Paul, MN 55144-1000

Phone: [phone]
Fax: [phone]
Date: July 16, 1996
Trade Name: 3M™ Dent System
Common Names: resin tooth bonding agent system,
resin-based dental adhesive system
Classification Name: resin tooth bonding agent (21CFR872.3200)

Predicate devices:
3M™ Scotchbond™ Multi-Purpose Plus Dental Adhesive System (K942493)
Prime & Bond™ Direct Composite Bonding Agent (K951864)
One Step™ Universal Dental Adhesive System (K# unknown)

The 3M™ Dent System is a simple adhesive system that offers the dental practitioner a wide range of applications. The 3M™ Dent System is substantially equivalent to the predicate devices above in that all are intended to be used as a 21 CFR 872.3200 resin tooth bonding agent. 3M™ Dent System is substantially equivalent to One Step™ Universal in terms of indications.

The design of the 3M™ Dent System is substantially equivalent to the predicate devices above because all utilize a phosphoric acid etchant and a methacrylate resin that will polymerize upon exposure to visible light from a dental light curing unit. The 3M™ Dent System, Prime & Bond™ and One Step™ Universal all utilize a resin that is intended to function as both primer and adhesive.

The performance of the 3M™ Dent System is substantially equivalent to the predicate devices above, based on nonclinical performance data including bond strength to dentin, enamel and various dental materials, dentin permeability and microleakage.

Biological safety assessment, conducted in accordance with ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing (with FDA modified matrix), does not raise any new safety concerns and indicates that 3M™ Dent Resin is safe for its intended use. The phosphoric acid etchant component of the 3M™ Dent System has already been legally marketed globally for several years with another 3M dental adhesive system. Use of this phosphoric acid etchant as part of the 3M™ Dent System does not raise any new safety concerns. Refer to precautionary language in the 3M™ Dent Instructions for Use.