[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR872.3220]

[Page 327]
 
                        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 D--Prosthetic Devices
 
Sec. 872.3220  Facebow.

    (a) Identification. A facebow is a device intended for use in 
denture fabrication to determine the spatial relationship between the 
upper and lower jaws. This determination is intended for use in placing 
denture casts accurately into an articulator (Sec. 872.3150) and thereby 
aiding correct placement of artificial teeth into a denture base.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9. If the device is 
not labeled or otherwise represented as sterile, the device is exempt 
from the current good manufacturing practice regulations in part 820 of 
this chapter, with the exceptions of Sec. 820.180, with respect to 
general requirements concerning records, and Sec. 820.198, with respect 
to complaint files.

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 
FR 38797, July 25, 2001]