GC RELINE SOFT/EXTRA SOFT by GC AMERICA, INC.

GC Reline Soft / Extra Soft is a resilient material for making soft relinings of dentures. The product is composed of denture relining Soft/Extra Soft, Primer (Primer R and Primer M) and Modifier and Silicone Points. Two types are available, Soft and Extra Soft.

Device Description

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance for "GC Reline Soft/Extra Soft". The document is a 510(k) clearance letter from the FDA, which determines substantial equivalence to a predicate device, allowing it to be marketed. It does not include details of performance studies, sample sizes, expert qualifications, or ground truth establishment.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 8 1995

Ms. Terry L. Joritz Director, Regulatory Affairs and Quality Assurance/Quality Control Official Correspondent GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803

Re : K990736 GC™ Reline Soft/Extra Soft Trade Name: Regulatory Class: II Product Code: EBI March 2, 1999 Dated: Received: March 5, 1999

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 aqainst 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister.

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Page 2 - Ms. Joritz

this response to your premarket notification Please note: 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.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA findinq 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 diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Patacro Cucerite/fa

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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INDICATIONS FOR USE

Device Name:

GC Reline Soft / Extra Soft

Indications for Use:

Prescription Use
(Per 21 CFR 801.109)

Susan Dunne

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number -196

Regulation Number and Section

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
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.(b)
Classification. Class II.