DINABASE (TM)

K971138 · Sultan Chemists, Inc. · EBI · Jul 21, 1997 · Dental

Device Facts

• Record ID: K971138
• Device Name: DINABASE (TM)
• Applicant: Sultan Chemists, Inc.
• Product Code: EBI · Dental
• Decision Date: Jul 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended to reline a denture surface that contacts tissue--for temporary or provisional usage. Not for OTC use.

Device Story

Dinabase™ is a dental material used to reline denture surfaces that contact oral tissue. It serves as a temporary or provisional liner. The device is applied by a dental professional in a clinical setting to improve denture fit and patient comfort. It is not intended for over-the-counter use. The material interfaces between the denture base and the patient's oral mucosa to provide a temporary cushion or adjustment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental relining material for temporary/provisional use. Formulated for application to denture surfaces contacting oral tissue.

Indications for Use

Indicated for patients requiring temporary or provisional relining of denture surfaces that contact tissue. Prescription use only.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Les Heimann
Director of Quality
Sultan Chemists, Incorporated
85 West Forest Avenue
Englewood, New Jersey 07631

Re: K971138
Trade Name: Dinabase™
Regulatory Class: II
Product Code: EBI
Dated: June 10, 1997
Received: June 11, 1997

JUL 21 1997

Dear Mr. Heimann:

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. 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 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 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

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Page 2 - Mr. Heimann

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 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 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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ATTACHMENT #4
REVISED INDICATIONS FOR USE
ORIGINAL

VIII.1 Indications for Use: [Separate Page]

510(k) Number: NA K971138

Device Name: DINABASE™

Intended to reline a denture surface that contacts tissue--for temporary or provisional usage. Not for OTC use.

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

Concurrence of CDRH, Office of Device Evaluation[ODR]

(Division Sign-Off) RSBot
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K 971138
Prescription Use
(Per 21 CFR 801.109

Over-The-Counter Use
(Optional Format 1-2-96)

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