A-SOFT RELINER

K984483 · S & C Polymer GmbH · EBI · Feb 18, 1999 · Dental

Device Facts

• Record ID: K984483
• Device Name: A-SOFT RELINER
• Applicant: S & C Polymer GmbH
• Product Code: EBI · Dental
• Decision Date: Feb 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For relining and rebasing dentures.

Device Story

A-Soft Reliner is a dental material used for relining and rebasing dentures. It is applied by dental professionals in a clinical setting to improve the fit and comfort of existing prosthetic appliances. The device functions as a soft liner to adjust the denture base to the patient's oral tissues, facilitating better retention and stability. It is intended for prescription use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental relining and rebasing material. Class II device (Product Code: EBI).

Indications for Use

Indicated for patients requiring relining or rebasing of dentures.

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 is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol is a representation of a human figure, with three wavy lines forming the body and head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 8 1999

Jürgen Ebgelbrecht, Ph.D. President S & C Polymer Silicon- und Composite-Spezialitäten GmbH Robert-Bosch-StraBe 5 D-25335 Elmshorn GERMANY

Re : K984483 Trade Name: A-Soft Reliner Regulatory Class: II Product Code: EBI Dated: February 3, 1999 Received: February 8, 1999

## Dear Dr. Engelbrecht:

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 legally marketed predicate 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 regulatory In addition, FDA may publish further announcements action. 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

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

Page 2 - Dr. Engelbrecht

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 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" (21CFR 807.97). Other qeneral 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/dsma/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}------------------------------------------------

S & C Polymer

ion - page 6 A-SOFT RELINER -

## 9. Statement of Indications for Use

510(k) Number (if known):

**Device Name:**

Indications for Use:

K984483

A-Soft Reliner

For relining and rebasing dentures.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runre

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

Prescription Use: ...

or

Over-The-Counter Use: