PERIMETRICS PERIOMETER

K072213 · Perimetrics, Inc. · EKX · Aug 29, 2008 · Dental

Device Facts

• Record ID: K072213
• Device Name: PERIMETRICS PERIOMETER
• Applicant: Perimetrics, Inc.
• Product Code: EKX · Dental
• Decision Date: Aug 29, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1

Intended Use

The Periometer is a unit that precisely measures the damping characteristics of the periodonium and its associated fixed structures (teeth and/or implants). It can provide data to quantify tooth and/or dental implant mobility.

Device Story

Periometer measures damping characteristics of periodontium and fixed structures (teeth/implants); quantifies tooth/implant mobility. Device used in dental clinical settings by practitioners to assess periodontal health. Input consists of physical damping measurements from dental structures; output provides quantitative mobility data. Clinicians use output to evaluate stability of teeth or implants, aiding in diagnosis and treatment planning for periodontal conditions.

Clinical Evidence

No clinical data provided; device cleared based on technological characteristics and intended use.

Technological Characteristics

Dental diagnostic instrument for measuring damping characteristics of periodontium and dental implants. Operates as a measurement unit for mobility quantification. Class I device under 21 CFR 872.4200.

Indications for Use

Indicated for the measurement of damping characteristics of the periodontium and associated fixed structures (teeth and/or implants) to quantify tooth and/or dental implant mobility.

Regulatory Classification

Identification

A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 2 9 2008

Perimetrics, Incorporated C/O Dr. Albert Rego Consultant 27001 La Paz Road, Suite 314 Mission Viejo, California 92691

Re: K072213

Trade/Device Name: Perimeterics, LLCTM Periometer™ Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX Dated: August 18, 2008 Received: August 19, 2008

Dear Dr. Rego:

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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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Susan Runoe

Chiu S. Lin. Ph. D Division 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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K072213

## Indications for Use

510(k) Number (if known): K072213

Device Name:

Perimetrics, LLC TM Periometer™

Indications for Use:

The Periometer is a unit that precisely measures the damping characteristics of the periodonium and its associated fixed structures (teeth and/or implants). It can provide data to quantify tooth and/or dental implant mobility.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE) unter Page 1 of ____________________________________________________________________________________________________________________________________________________________________ (Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K072213