[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR872.2060]

[Page 340]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 872_DENTAL DEVICES--Table of Contents
 
                      Subpart B_Diagnostic Devices
 
Sec. 872.2060  Jaw tracking device.

    (a) Jaw tracking device for monitoring mandibular jaw positions 
relative to the maxilla--(1) Identification. A jaw tracking device for 
monitoring mandibular jaw positions relative to the maxilla is a 
nonpowered or electrically powered device that measures and records 
anatomical distances and angles in three dimensional space, to determine 
the relative position of the mandible with respect to the location and 
position of the maxilla, while at rest and during jaw movement.
    (2) Classification. Class I (general controls). The device is exempt 
from the premarket notification provisions of subpart E of part 807 of 
this chapter subject to Sec. 872.9.
    (b) Jaw tracking device for interpretation of mandibular jaw 
positions for the diagnosis--(1) 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.
    (2) 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.''

[68 FR 67367, Dec. 2, 2003]

Subpart C [Reserved]