(50 days)
Ufi Gel C is intended for use as a permanently soft relining for total and partial dentures.
- to relieve pressure from pressure spots
- to dam the palatal vibrating line in cases of flabby ridge and insufficient adhesion
- to cushion sharp-edged alveolar processes
- to support the healing process in implantology
Not Found
The provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device called "UFI Gel C." This document does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device.
The letter is a regulatory approval for marketing the device based on a determination of substantial equivalence to a predicate device marketed before May 28, 1976. It outlines the general controls and potential additional controls applicable to the device.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study that proves the device meets them, as this information is not present in the provided document. The request specifically asks for details relevant to AI/ML device studies (e.g., sample sizes, ground truth, experts, MRMC studies, standalone performance), none of which are mentioned here.
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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, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 0 1998
VOCO GmbH C/O Mr. Evan Dick E.G. Dick & Associates 7527 Westmoreland Avenue St. Louis, Missouri 63105
Re : K974772 Trade Name: UFI Gel C Requlatory Class: II Product Code: EBI Dated: December 22, 1997 Received: December 22, 1997
Dear Mr. Dick:
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, qood 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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
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Page 2 - Mr. Dick
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 (301) 594-4618. 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,
Timothy A. Ulatowski
Timothy Directdr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K974772
Device Name: Ufi Gel C
Indications For Use:
Ufi Gel C is intended for use as a permanently soft relining for total and partial dentures.
- to relieve pressure from pressure spots
- to dam the palatal vibrating line in cases of flabby ridge and insufficient adhesion
- to cushion sharp-edged alveolar processes
- to support the healing process in implantology
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
| 510(k) Number | K974772 |
|---|---|
| --------------- | --------- |
| Prescription Use | OR | Over-The-Counter Use | |
|---|---|---|---|
| (per 21 CFR 801.109) |
§ 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.