[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR874.3695]

[Page 338-339]
 
                        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

[[Page 339]]

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