[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: 21CFR872.3060]

[Page 340-341]
 
                        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. 872.3060  Noble metal alloy.

    (a) Identification. A noble metal alloy is a device composed 
primarily of noble metals, such as gold, palladium, platinum, or silver, 
that is intended for use

[[Page 341]]

in the fabrication of cast or porcelain-fused-to-metal crown and bridge 
restorations.
    (b) Classification. Class II (special controls). The special control 
for these devices is FDA's ``Class II Special Controls Guidance 
Document: Dental Noble Metal Alloys.'' The devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec. 872.9. See Sec. 872.1(e) 
for availability of guidance information.

[69 FR 51766, Aug. 23, 2004]