UFI GEL HARD

K993827 · Voco GmbH · EBI · Jan 20, 2000 · Dental

Device Facts

• Record ID: K993827
• Device Name: UFI GEL HARD
• Applicant: Voco GmbH
• Product Code: EBI · Dental
• Decision Date: Jan 20, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Ufi Gel hard is an acrylic resin used as a permanent hard relining for complete and partial dentures.

Device Story

Ufi Gel hard is an acrylic resin material used by dental professionals for the permanent hard relining of complete and partial dentures. The device is applied chairside to the denture base to improve fit and stability. It functions as a restorative dental material to address denture looseness or discomfort. The provider mixes and applies the resin to the denture, which then cures to form a hard, durable lining. This process restores proper occlusion and retention, potentially improving patient comfort and masticatory function.

Clinical Evidence

Bench testing only.

Technological Characteristics

Acrylic resin-based dental material; permanent hard relining composition; chemical curing mechanism; supplied as a multi-component system for chairside mixing and application.

Indications for Use

Indicated for permanent hard relining of complete and partial dentures in patients requiring denture adjustment or repair.

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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, with flowing lines connecting them. The overall design is simple and conveys a sense of unity and connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 20 2000

Shuojia Donq, Ph.D. DenPlus, Incorporated 4235 Beaconsfield Montreal, Quebec, Canada H4A 2H4

Re : K993827 Ufi Gel Hard Trade Name: Regulatory Class: II Product Code: EBI Dated: January 11, 2000 Received: January 12, 2000

Dear Dr. Donq:

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 Regulations, Title 21, Parts 800 to 895. ದ 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

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Page 2 - Dr. Dong

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 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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510 (k) NUMBER (IF KNOWN) :

DEVICE NAME : Ufi Gel hard

INDICATIONS FOR USE :

Ufi Gel hard is an acrylic resin used as a permanent hard relining for complete and partial dentures.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED.)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
|------------------------------------------------------------------------|----|---------------------------------------------|
| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter-Use<br>(Optional Format 1) |
| | | |
| (Division Sign-Off) | | |
| Division of Dental, Infection Control.<br>and General Hospital Devices | | |

510(k) Number _