KERR HARD DENTURE RELINE MATERIAL

K981448 · Sybron Dental Specialties, Inc. · EBI · Jun 16, 1998 · Dental

Device Facts

• Record ID: K981448
• Device Name: KERR HARD DENTURE RELINE MATERIAL
• Applicant: Sybron Dental Specialties, Inc.
• Product Code: EBI · Dental
• Decision Date: Jun 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Kerr Hard Denture Reline Material is intended for the restoration of function and form in dentures which have become ill-fitting due to alveolar bone loss over a period of time.

Device Story

Kerr Hard Denture Reline Material is a paste/paste methacrylate-based system used to reline ill-fitting dentures. It is applied by dental professionals in either a dental office or laboratory setting. The material restores function, comfort, and esthetics to dentures compromised by alveolar bone loss. It functions as a restorative resin for denture relining, repair, or rebasing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Paste/paste methacrylate-based resin system. Class II device (21 CFR § 872.3760).

Indications for Use

Indicated for patients requiring restoration of function and form in dentures that have become ill-fitting due to alveolar bone loss over time.

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.

Predicate Devices

• Kooliner, GC America

Submission Summary (Full Text)

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Ka8 1448

# Section III - 510(k) Summary of Safety and Effectiveness

### Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 [phone] - Phone [phone] - Facsimile Wendy A. Urtel - Contact Person

Date Summary Prepared: April 1998

## Device Name:

- Trade Name Kerr Hard Denture Reline Material ●
- Common Name Hard Denture Reline Material ●
- Classification Name Denture Relining, Repairing or Rebasing Resin . 21 CFR § 872.3760

#### Device for Which Substantial Equivalence is Claimed:

- Kooliner, GC America ●
#### Device Description:

The device is a paste/paste methacrylate based system for restoring function, comfort and esthetics to ill-fitting dentures. The system can be used either in the dental office or in the dental laboratory for relining of dentures.

#### Intended Use of the Device:

The intended use of Kerr Hard Denture Reline Material is for the restoration of function and form in dentures which have become ill-fitting due to alveolar bone loss over a period of time.

#### Substantial Equivalence:

The hard denture reline material is substantially equivalent to other legally marketed devices in the United States. The hard denture reline material marketed by GC America functions in a manner similar to and is intended for the same use as the product manufactured by Kerr Corporation.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 6 1998

Ms. Wendy A. Urtel Regulatory Affairs Specialist Sybron Dental Specialties, Incorporated 1717 W. Collins Avenue Orange, California 92667

K981448 Re : Kerr Hard Denture Reline Material Trade Name: Requlatory Class: II Product Code: EBI Dated: April 17, 1997 Received: April 22, 1998

Dear Ms. Urtel:

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, Druq, 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. বৈ 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 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 requlations.

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Page 2 - Ms. Urtel

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" (21 CFR 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/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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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Section I - Indications for Use

510(k) Number: K981442

Device Name: Kerr Hard Denture Reline Material

Indications for Use:

لقابل المنتخب

Kerr Hard Denture Reline Material is intended for the restoration of function and form in Rell Hard Denture Remis Material in the new lass over a period of time.

Susan Rumm

l

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