FIT CHECKER II

K032289 · GC America, Inc. · ELW · Oct 20, 2003 · Dental

Device Facts

• Record ID: K032289
• Device Name: FIT CHECKER II
• Applicant: GC America, Inc.
• Product Code: ELW · Dental
• Decision Date: Oct 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

Silicone fit examining material used to detect high spots and pressure points of crowns, bridges, veneers, inlays and dentures .

Device Story

FIT CHECKER II is a silicone-based impression material used by dental professionals to evaluate the fit of dental prosthetics. The material is applied to the internal surface of crowns, bridges, veneers, inlays, or dentures. When the prosthetic is seated in the patient's mouth, the material records areas of high contact or pressure. After removal, the clinician visually inspects the material to identify high spots or pressure points, allowing for precise adjustment of the restoration. This process ensures proper seating and comfort for the patient, reducing the risk of post-insertion complications.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Silicone-based impression material. Formulated for high-precision detection of pressure points in dental restorations. Supplied as a multi-component system for mixing. Non-sterile, dental-use material.

Indications for Use

Indicated for use by dental professionals to detect high spots and pressure points in dental restorations including crowns, bridges, veneers, inlays, and dentures.

Regulatory Classification

Identification

Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

Special Controls

*Classification.* Class II (Special Controls).

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human profiles or a bird-like figure with three sets of wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 0 2003

Ms. Terry L. Joritz Director. Regulatory Affairs and Quality Control GC America. Incorporated 3737 West 127th Street Alsip, Illinois 60803

Re: K032289

Trade/Device Name: FIT CHECKER II Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: July 23, 2003 Received: August 11, 2003

Dear Ms. Joritz:

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 - Ms. Terry L. Joritz

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 vour 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 [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 Part 807.97) you may obtain. Other general information on vour responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,.

Sinerhunne

Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: _____________FIT_CHECKER II

## Indications For Use:

Silicone fit examining material used to detect high spots and pressure points of crowns, bridges, veneers, inlays and dentures .

1203229

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use <span style="text-decoration: overline;">✓</span><br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use <span style="text-decoration: overline;"></span><br>(Optional Format 1-2-96). |
|--------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| | <center>Susan Runni</center><br>(Division Sign-Off)<br>Division of Anesthesiology, General Hospital,<br>Infection Control, Dental Devices<br>X-2-289 | |

510(k) Number _