BOSWORTH DENTIN RESIN

K061611 · Harry J. Bosworth Co. · KLE · Sep 11, 2006 · Dental

Device Facts

• Record ID: K061611
• Device Name: BOSWORTH DENTIN RESIN
• Applicant: Harry J. Bosworth Co.
• Product Code: KLE · Dental
• Decision Date: Sep 11, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

The Bosworth Dentin Resin is used with either an acid etchant or a self-etch bond to provide a light-cure bond for bonding dental resin composites, resin luting cements, orthodontic adhesives and resin sealalnts to tooth structures - tooth enamel and dentin. It is indicated for use with light-cure, self-cure (autopolymerizable) and dual-cure (light-cure and/or self-cure combination) resin based materials. The Bosworth Dentin Resin can also be used with the same light-curable, selfcurable and dual-curable resin based materials to bond to ceramic and metal surfaces including dental amalgam.

Device Story

Bosworth Dentin Resin is a dental bonding agent used by dentists to facilitate adhesion between restorative materials and tooth structures or prosthetic surfaces. It functions as an interface material, applied to prepared tooth surfaces (enamel/dentin) or restorative substrates (ceramic/metal/amalgam) to ensure chemical or micromechanical bonding of resin-based composites, cements, or adhesives. The device is applied chairside by a dental professional. It supports various polymerization modes, including light-cure, self-cure, and dual-cure, allowing versatility in clinical restorative procedures. By providing a reliable bond, it aids in the retention and marginal integrity of dental restorations, potentially reducing microleakage and secondary caries.

Clinical Evidence

Bench testing only.

Technological Characteristics

Resin-based dental bonding agent. Designed for compatibility with light-cure, self-cure, and dual-cure resin systems. Formulated for application to tooth structures (enamel/dentin) and restorative materials (ceramic/metal/amalgam).

Indications for Use

Indicated for bonding dental resin composites, luting cements, orthodontic adhesives, and sealants to tooth enamel, dentin, ceramic, and metal surfaces (including amalgam). Compatible with light-cure, self-cure, and dual-cure resin-based materials.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 1 1 2006

Ms. Mildred M. Goldstein President Harry J. Bosworth Company 7227 North Hamlin Avenue Skokie, Illinois 60076

Re: K061611

Trade/Device Name: Bosworth Dentin Resin Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: July 27, 2006 Received: July 31, 2006

Dear Ms. Goldstein:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may. therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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## Page 2 – Ms. Mildred M. Goldstein

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clare

Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(K) Number: K061611

Device Name: Bosworth Dentin Resin

## INDICATIONS FOR USE:

The Bosworth Dentin Resin is used with either an acid etchant or a self-etch bond to provide a light-cure bond for bonding dental resin composites, resin luting cements, orthodontic adhesives and resin sealalnts to tooth structures - tooth enamel and dentin. It is indicated for use with light-cure, self-cure (autopolymerizable) and dual-cure (light-cure and/or self-cure combination) resin based materials.

The Bosworth Dentin Resin can also be used with the same light-curable, selfcurable and dual-curable resin based materials to bond to ceramic and metal surfaces including dental amalgam.

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