§ 872.3060. Noble metal alloy.
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/us/cfr/t21/s§ 872.3060·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]