SUPER SEAL

K983477 · Phoenix Dental, Inc. · EJK · Dec 22, 1998 · Dental

Device Facts

• Record ID: K983477
• Device Name: SUPER SEAL
• Applicant: Phoenix Dental, Inc.
• Product Code: EJK · Dental
• Decision Date: Dec 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3250
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Super Seal is a potassium oxalate based film forming acid resistant liner and desensitizer that is indicated for application prior to restoration of exposed dentin.

Device Story

Super Seal is a potassium oxalate-based, film-forming dental liner and desensitizer. It is applied by dental professionals to exposed dentin surfaces prior to the placement of dental restorations. The device functions by forming an acid-resistant layer on the dentin, which serves to desensitize the tooth and protect the dentin surface during the restorative process. It is intended for prescription use in a clinical dental setting.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on bench testing and regulatory review.

Technological Characteristics

Potassium oxalate-based film-forming liquid. Applied as a liner/desensitizer. Class II device, Product Code EJK.

Indications for Use

Indicated for application prior to restoration of exposed dentin in patients requiring dental restorative procedures.

Regulatory Classification

Identification

A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth.

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 22 1998

Mr. Robert A. Cherba Operation Manager Phoenix Dental, Incorporated 3452 West Thompson Road Fenton, Michigan 48430

K983477 Re : Super Seal Trade Name: Requlatory Class: II Product Code: EJK Dated: September 29, 1998 October 2, 1998 Received:

Dear Mr. Cherba:

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 leqally 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 requlations 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 General requlation (21 CFR Part 820) and that, Devices: 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 obliqation you miqht have under sections 531

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Page 2 - Mr. Cherba

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 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/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timotiy 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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## 1 1 Page of

K983477 510(k) Number (if known): Super Seal Device Name:_

Indications For Use:

Super Seal is a potassium oxalate based film forming acid resistant liner and desensitizer that is indicated for application prior to restoration of exposed dentin.

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

Supo Rume

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

Prescription Use レ (Per 21 CFR 801.109)

7

OR

Over-The-Counter Use