(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 Sec. 872.9. See Sec. 872.1(e) for availability of guidance information. [69 FR 51766, Aug. 23, 2004]