21 CFR 872.2060 — Device, Jaw Tracking, For Diagnosis Of Tmj / Mpd Disorders
Dental (DE) · Subpart B—Diagnostic Devices · § 872.2060
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.
Classification Rationale
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.”
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| NFR | Device, Jaw Tracking, For Diagnosis Of Tmj / Mpd Disorders | 2 | 0 | |
| NFS | Device, Jaw Tracking, For Monitoring Jaw Positions | 1 | 2 |
Special Controls
NFR — Device, Jaw Tracking, For Diagnosis Of Tmj / Mpd Disorders
*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.”
eCFR
NFR — Device, Jaw Tracking, For Diagnosis Of Tmj / Mpd Disorders
The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Dental Sonography and Jaw Tracking Devices.”
Ecfr Llm
NFS — Device, Jaw Tracking, For Monitoring Jaw Positions
*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.”
eCFR
