USFDA - Subpart D -- Prosthetic Devices - Sec. 872.3580 Preformed gold denture tooth

USFDA - Subpart D -- Prosthetic Devices - Sec. 872.3580 Preformed gold denture tooth
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2004]
[CITE: 21CFR872.3580]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES
PART 872 -- DENTAL DEVICES
Subpart D -- Prosthetic Devices
Sec. 872.3580 Preformed gold denture tooth.
(a) Identification. A preformed gold denture tooth is a device composed of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended for use as a tooth or a portion of a tooth in a fixed or removable partial denture.
(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 ¨? 872.9.
[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, 2001]