21 C.F.R. § 872.3710

Current through February 29, 2024
Section 872.3710 - Base metal alloy
(a)Identification. A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.
(b)Classification. Class II (special controls). The special control for this device is FDA's "Class II Special Controls Guidance Document: Dental Base Metal Alloys." 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 . See § 872.1(e) for availability of guidance information.

21 C.F.R. §872.3710

69 FR 51766, Aug. 23, 2004