# Dental Devices; Dental Noble Metal Alloys and Dental Base Metal Alloys; Designation of Special Controls
> **Food and Drug Administration** · Final rule. · Published 2004-08-23 · Effective 2004-09-22 · 69 FR 51765
## Document
- **Document number:** 04-19178
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 69 FR 51765
- **CFR reference:** 21 CFR 872
- **Publication date:** 2004-08-23
- **Effective date:** 2004-09-22
- **HHS docket:** Docket No. 2003N-0390
## Abstract

The Food and Drug Administration is amending the identification and classification regulations of gold-based alloys and precious metal alloys for clinical use and base alloys devices in order to designate a special control for these devices. FDA is also exempting these devices from premarket notification requirements. The agency is taking this action on its own initiative. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the draft guidance documents that would serve as special controls for these devices.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2004/08/23/04-19178/dental-devices-dental-noble-metal-alloys-and-dental-base-metal-alloys-designation-of-special)
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