[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: 21CFR874.3695]

[Page 351-352]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 874--EAR, NOSE, AND THROAT DEVICES--Table of Contents
 
                      Subpart D--Prosthetic Devices
 
Sec. 874.3695  Mandibular implant facial prosthesis.

    (a) Identification. A mandibular implant facial prosthesis is a 
device that is intended to be implanted for use in the functional 
reconstruction of mandibular deficits. The device is made of materials 
such as stainless steel, tantalum, titanium, cobalt-chromium

[[Page 352]]

based alloy, polytetrafluoroethylene, silicone elastomer, polyethylene, 
polyurethane, or polytetrafluoroethylene with carbon fibers composite.
    (b) Classification. Class II.