UNI-FLEX RESIN

K983461 · Trans-Atlantic Dental · EBI · Apr 13, 1999 · Dental

Device Facts

• Record ID: K983461
• Device Name: UNI-FLEX RESIN
• Applicant: Trans-Atlantic Dental
• Product Code: EBI · Dental
• Decision Date: Apr 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2

Intended Use

Uni-flex Resin is a flexible material that is used to produce the denture base in prosthetic partials.

Device Story

Uni-Flex Resin is a flexible material for denture base fabrication in prosthetic partials. Material is supplied in aluminum cartridges designed for use with an Injection Mold System machine. Operation involves heating the cartridge to 490°F for ten minutes until molten; the operator then manually turns the machine handle to inject the material into a prepared dental mold within an Injection Mold Flask. Post-injection, the flask undergoes a three-minute cool-down on the machine, followed by a twenty-minute bench cool-down before mold removal. The resulting denture base is then finished and polished. Used in dental laboratory settings by dental technicians.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Flexible resin material supplied in aluminum cartridges. Processing requires thermal heating to 490°F and mechanical injection molding. No software or electronic components.

Indications for Use

Indicated for use as a flexible material for the fabrication of denture bases in prosthetic partials.

Regulatory Classification

Identification

A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 3 1999

Ms. Caroline M. Zaleski Trans-Atlantic Dental 46 Arctic Parkway Trenton, New Jersey 08638

Re : K983461 Trade Name: Uni-Flex Resin Requlatory Class: II Product Code: EBI January 11, 1999 Dated: Received: January 14, 1999

Dear Ms. Zaleski:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Zaleski

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

Director

Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Trans-Atlantic Dental 46 Arctic Parkway Trenton, NJ 08638 Tel/Fax [phone] Indications for Use Statement

## Device Name: Uni-Flex Resin

Uni-flex Resin is a flexible material that is used to produce the denture base in prosthetic partials.

This material is packed and sealed in aluminum cartridges which are especially made to fit the Injection Mold System machine. To begin the production of a partial a cartridge is heated to 490'F. This allows the material becomes molten. The process of melting lasts ten minutes. After the material becomes molten the operator turns the handle of the Injection Mold System. This forces the material to inject into a previously prepared dental mold encased in an Injection Mold Flask. After the injection the cool down period lasts three minutes, the operator must remove the flask from the machine during this time. Then a twenty minute bench cool down period follows, only after the twenty minutes mold is removed from the flask. After this elapsed time the denture is now ready for finishing and high shine polish.

Susan Purrer

Division Sign-Orf Division of Dental, Infection Cont and General Hospital Devic 510(k) Number

NOT A PRESCRIPTION