JT-3 ELECTROGNATHOGRAPH

K952218 · Bio-Research Associates, Inc. · NFS · Sep 21, 1995 · Dental

Device Facts

• Record ID: K952218
• Device Name: JT-3 ELECTROGNATHOGRAPH
• Applicant: Bio-Research Associates, Inc.
• Product Code: NFS · Dental
• Decision Date: Sep 21, 1995
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.2060
• Device Class: Class 1

Device Story

The JT-3 Electrognathograph is a jaw tracking device used to monitor and record mandibular movement. It functions by tracking the position of the jaw, providing data for dental or orthodontic assessment. The device is intended for use in a clinical setting by dental professionals to assist in the evaluation of jaw function and movement patterns. It provides objective measurements of mandibular motion, which clinicians use to inform diagnosis and treatment planning for temporomandibular disorders or occlusal analysis.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory classification and historical market presence.

Technological Characteristics

Jaw tracking device; 21 CFR 872.2060; Product Code NFS; Class I. Technical specifications and materials not detailed in the provided documentation.

Regulatory Classification

Identification

A jaw tracking device for interpretation of mandibular jaw positions relative to the maxilla for the diagnosis of temporomandibular joint disorders and associated orofacial pain is a nonpowered or electrically powered device that measures and records anatomical distances and angles to determine the relative position of the mandible in three dimensional space, with respect to the location and position of the maxilla, while at rest and during jaw movement. The device records, displays, and stores information about jaw position. The device interprets jaw position to generate meaningful output, either directly or by connection to a personal computer. The device may be a part of a system of devices, contributing jaw position information to be considered with data from other diagnostic components.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Dental Sonography and Jaw Tracking Devices.”

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

AUG 15 2005

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. John Radke

Bio-Research Associates, Inc.

9275 North 49th St.

Brown Deer, Wisconsin 53223

Re: K952218

Trade/Device Name: JT-3 Electrognathograph

Regulation Number: 21 CFR 872.2060

Regulation Name: Jaw tracking device

Regulatory Class: I

Product Code: NFS

Dated: August 17, 1995

Received: August 21, 1995

Dear Mr. Radke:

This letter corrects our substantially equivalent letter of September 21, 1995, regarding the classification of your device which was incorrectly identified as "unclassified."

We have reviewed your Section 510(k) notification of intent to market the device referenced above and have determined the device is substantially equivalent to 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 – Mr. John Radke

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. An 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, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA.

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]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or at [phone].

Sincerely yours,

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