UNIFAST III

K073106 · GC America, Inc. · EBG · Apr 11, 2008 · Dental

Device Facts

• Record ID: K073106
• Device Name: UNIFAST III
• Applicant: GC America, Inc.
• Product Code: EBG · Dental
• Decision Date: Apr 11, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Unifast III is a self-curing acrylic resin used for a variety of dental applications, including construction of temporary inlays, crowns and bridges and repair of fractured dentures in either pressure or paint on techriiques.

Device Story

Unifast III is a self-curing acrylic resin used by dental professionals in clinical settings for the fabrication of temporary dental restorations (inlays, crowns, bridges) and the repair of fractured dentures. The material is applied using either pressure or paint-on techniques, allowing the clinician to mold the resin directly or indirectly. The resin cures to form a durable temporary structure, facilitating patient function and aesthetics while permanent restorations are prepared. It serves as a restorative material for temporary dental applications.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Self-curing acrylic resin; chemical composition typical of dental relining/repair resins; supplied as a powder/liquid system; polymerization via chemical initiation; intended for chairside dental application.

Indications for Use

Indicated for dental patients requiring temporary inlays, crowns, bridges, or repair of fractured dentures. Used by dental professionals via pressure or paint-on techniques.

Regulatory Classification

Identification

A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" are arranged in a circle around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mark Heiss D.D.S. Director, Professional Relations & Regulatory Affairs GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803

APR 11 2008

Re: K073106

Trade/Device Name: Unifast III Regulation Number: 872.3760 Regulation Name: Denture Relining Repairing or Rebasing Resin Regulatory Class: II Product Code: EBI, EBG Dated: March 19, 2008 Received: March 24, 2008

Dear Dr. Heiss:

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 - Dr. Heiss

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" (21CFR Part 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.

Chiu-Lin, Ph.D.

Chiu Lin, Ph.D. 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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## Indications for Use

510(k) Number (if known): K073106

Device Name: Unifast III

Indications for Use: Unifast III is a self-curing acrylic resin used for a variety of dental applications, including construction of temporary inlays, crowns and bridges and repair of fractured dentures in either pressure or paint on techriiques.

Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Swser Summe

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: X673101