UFI GEL C

K974772 · Voco GmbH · EBI · Feb 10, 1998 · Dental

Device Facts

• Record ID: K974772
• Device Name: UFI GEL C
• Applicant: Voco GmbH
• Product Code: EBI · Dental
• Decision Date: Feb 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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

Device Story

Ufi Gel C is a permanently soft relining material for total and partial dentures. Applied by dental professionals in a clinical setting to improve denture fit and patient comfort. Functions by providing a resilient interface between the denture base and oral mucosa; relieves pressure on sensitive areas; cushions sharp alveolar ridges; aids in sealing palatal margins; supports post-implant healing. Output is a soft, durable liner within the denture prosthesis. Benefits include reduced patient discomfort, improved denture retention, and facilitated tissue healing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Permanently soft denture relining material. Chemical composition and physical properties consistent with class II dental relining materials. Formulated for direct application to denture bases.

Indications for Use

Indicated for patients requiring permanently soft relining for total or partial dentures to relieve pressure spots, dam the palatal vibrating line (flabby ridge/insufficient adhesion), cushion sharp-edged alveolar processes, or support healing in implantology.

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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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 [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

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 | <img alt="Check" src="check.png"/> | OR | Over-The-Counter Use |
|----------------------|------------------------------------|----|----------------------|
| (per 21 CFR 801.109) | | | |