21 C.F.R. § 872.3060 Noble metal alloy.
Title 21 - Food and Drugs
(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 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 §872.9. See §872.1(e) for availability of guidance information. [69 FR 51766, Aug. 23, 2004]
Title 21: Food and Drugs
PART 872—DENTAL DEVICES
Subpart D—Prosthetic Devices
§ 872.3060 Noble metal alloy.
