---
kind: "section"
citation: "21 C.F.R. § 872.3060"
title: "21"
number: "872.3060"
heading: "Noble metal alloy."
url: "https://uscodex.org/cfr/21/872.3060"
---

# §872.3060. Noble metal alloy.

- (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](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 872.9](/cfr/21/872.9.md). See [§ 872.1(e)](/cfr/21/872.1.md?p=e) for availability of guidance information.

## Notes

### Amendments

[69 FR 51766, Aug. 23, 2004]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 52 FR 30097, Aug. 12, 1987, unless otherwise noted.

### Amendments

[69 FR 51766, Aug. 23, 2004]