GC UNIFAST TRAD

K984365 · GC America, Inc. · EBI · Feb 25, 1999 · Dental

Device Facts

• Record ID: K984365
• Device Name: GC UNIFAST TRAD
• Applicant: GC America, Inc.
• Product Code: EBI · Dental
• Decision Date: Feb 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

GC Unifast Trad is an acrylic resin used in a variety of dental applications such as repair of full or partial acrylic dentures. Construction of temporary crowns. Impression trays for individual teeth. Check bit registration. Construction and repair of orthodontic plates and splints.

Device Story

GC Unifast Trad is a dental acrylic resin material. It is used by dental professionals in a clinical setting to fabricate or repair dental prosthetics and appliances. The material is applied by the clinician to create temporary crowns, impression trays, orthodontic plates, and splints, or to repair existing acrylic dentures. It functions as a restorative and prosthetic material, allowing the clinician to customize dental devices chairside. The output is a hardened acrylic structure that aids in patient treatment, restoration, or diagnostic procedures. It benefits patients by providing immediate temporary solutions or necessary repairs to dental appliances.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Acrylic resin dental material. Formulated for use in dental prosthetics and appliances. Material properties consistent with standard dental acrylic resins used for temporary crowns, trays, and repairs.

Indications for Use

Indicated for dental patients requiring repair of full or partial acrylic dentures, construction of temporary crowns, fabrication of individual impression trays, check bite registration, and construction or repair of orthodontic plates and splints.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the words "Public Health Service" in bold, black font. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line. The text appears to be extracted from a document or sign.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 5 1999

Ms. Terry L. Joritz Director-Regulatory Affairs & Quality Control Official Correspondent GC AMERICA INCORPORATED 3737 West 127th Street Alsip, Illinois 60803

K984365 Re: GC Unifast Trad Trade Name: Requlatory Class: II EBI/EBG Product Code: February 15, 1999 Dated: February 19, 1999 Received:

Dear Ms. Joritz:

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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Regulations, 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

{1}------------------------------------------------

Page 2 - Ms. Joritz

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA debering of substantial equivalence of your device to a legally marketed predicate device results in a classification for your markets 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 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 gener Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance obtained from choner (800) 638-204) 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

{2}------------------------------------------------

## Attachment A

## INDICATIONS FOR USE

Device Name:

## GC Unifast Trad

## Indications for Use

- GC Unifast Trad is an acrylic resin used in a variety of dental applications such as repair of ・・・ー full or partial acrylic dentures. Construction of temporary crowns. Impression trays for individual teeth. Check bit registration. Construction and repair of orthodontic plates and splints.
!

Susan Russn
(Division Sign-Off)

(Division of Dental, Infection Control, and General Hospital, In 510(k) Number .

↓

Prescription Use -------------------------------------------------------------------------------------------------------------------------------------------------------------Prescription Oso 109)
(Per 21 CFR 801.109)