[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: 21CFR872.2050]

[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. 872.2050  Dental sonography device.

    (a) Dental sonography device for monitoring--(1) Identification. A 
dental sonography device for monitoring is an electrically powered 
device, intended to be used to monitor temporomandibular joint sounds. 
The device detects and records sounds made by the temporomandibular 
joint.
    (2) Classification. Class I. The device is exempt from the premarket 
notification provisions of subpart E of part 807 of this chapter subject 
to Sec. 872.9.
    (b) Dental sonography device for interpretation and diagnosis--(1) 
Identification. A dental sonography device for interpretation and 
diagnosis is an electrically powered device, intended to interpret 
temporomandibular joint sounds for the diagnosis of temporomandibular 
joint disorders and associated orofacial pain. The device detects, 
records, displays, and stores sounds made by the temporomandibular joint 
during jaw movement. The device interprets these sounds to generate 
meaningful output, either directly or by connection to a personal 
computer. The device may be part of a system of devices, contributing 
joint sound 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]