FLEX-STAR V

K072402 · Cmp Industries, LLC · EBI · Oct 19, 2007 · Dental

Device Facts

• Record ID: K072402
• Device Name: FLEX-STAR V
• Applicant: Cmp Industries, LLC
• Product Code: EBI · Dental
• Decision Date: Oct 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CMP's Flex-Star V is used for the fabrication of partial or full removable dentures, as well as occusal splints and night guards. It is to be used only by professional dental practitioners who make or repair dentures for patients

Device Story

Flex-Star V is a dental resin material used by professional dental practitioners for the fabrication of partial or full removable dentures, occlusal splints, and night guards. The device functions as a restorative material in a clinical or laboratory setting to create or repair dental prosthetics. It is applied by dental professionals to improve patient oral function and comfort through the provision of custom-fitted dental appliances.

Clinical Evidence

Bench testing only.

Technological Characteristics

Denture relining, repairing, or rebasing resin. Class II device. Product code EBI.

Indications for Use

Indicated for use by professional dental practitioners for the fabrication of partial or full removable dentures, occlusal splints, and night guards.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 9 2007

Mr. Devon O. Howe President and Chief Executive Officer CMP Industries LLC 413 North Pearl Street Albany, New York 12207-1311

Re: K072402

Trade/Device Name: Flex-Star V Regulation Number: 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: August 24, 2007 Received: August 27, 2007

Dear Mr. Howe:

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 includerequirements 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.

{1}------------------------------------------------

Page 2- Mr. Howe

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sytte L. Michael Davis

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

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known): K072402

Device Name: Flex-Star V Indications for Use:

CMP's Flex-Star V is used for the fabrication of partial or full removable dentures, as well as occusal splints and night guards. It is to be used only by professional dental practitioners who make or repair dentures for patients

AND/OR

Prescription Use × (21 CFR Part 801 Subpart D) Over-The-Counter Use (21 CFR Part 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Quane

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

510(k) Number: K072462

Page 1 of 1