← Product Code [MQC](/productcode/MQC) · K030832

# PRIMOSPLINT SYSTEM (K030832)

_Cosmedent, Inc. · MQC · Sep 17, 2003 · DE · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K030832

## Device Facts

- **Applicant:** Cosmedent, Inc.
- **Product Code:** [MQC](/productcode/MQC.md)
- **Decision Date:** Sep 17, 2003
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** DE
- **Attributes:** Therapeutic

## Indications for Use

Primosplint System should be used for producing functional therapy and bite splints.

## Device Story

Primosplint is a light-cured composite material used to fabricate functional therapy and bite splints. The device is processed outside the mouth using stone models as a base. Once fabricated, the splint can be finished via mechanical polishing or the application of a glaze. The system is intended for use by dental professionals in a clinical or laboratory setting to create custom dental appliances for patient therapy.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Light-cured composite material; fabricated extra-orally on stone models; finished via mechanical polishing or glaze application. Chemical composition details provided in confidential appendix.

## Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows a circular logo with the words "PUBLIC HEALTH SERVICE" written around the top half of the circle and "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the bottom half of the circle. Inside the circle is a stylized image of an eagle with three lines representing its wings. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 7 2003

Mr. Michael O` Malley President Cosmedent Company Incorporated 401 North Michigan Avenue Suite 2500 Chicago, Illinois 60611

Re: K030832

Trade/Device Name: Primosplint System Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: MQC Dated: June 30, 2003 Received: July 1, 2003

Dear Mr. O' Malley:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 -Mr. O' Malley

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Kunnen

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## COSMEDENT®

## INDICATIONS FOR USE STATEMENT

510(kK) Number (if known):

…

K030832.

Device Name:

Primosplint System

Indication for Use:

Use for:

Primosplint System should be used for producing functional therapy and bite splints.

## DESCRIPTION OF DEVICE

Primosplint is a light composite developed for functional therapy bite splints and other applications. It is fabricated outside of the mouth from stone models. It may be polished mechanically or by the use of a glaze.

A confidential chemical analysis of Primosplint System may be found in Rein Maly SachSR Appendix B.

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

| 510(k) Number: | K030832 |
|----------------|---------|
|----------------|---------|

(PLEASE DO NOT WRITE BELOW THIS LINE)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-the Counter Use

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**Source:** [https://fda-staging.innolitics.com/device/K030832](https://fda-staging.innolitics.com/device/K030832)

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