# Dental Devices: Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation of Special Controls for Dental Amalgam, Mercury, and Amalgam Alloy
> **Food and Drug Administration** · Final rule. · Published 2009-08-04 · Effective 2009-11-02 · 74 FR 38686
## Document
- **Document number:** E9-18447
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 74 FR 38686
- **CFR reference:** 21 CFR 872
- **Publication date:** 2009-08-04
- **Effective date:** 2009-11-02
- **HHS docket:** Docket No. FDA-2008-N-0163
## Abstract

The Food and Drug Administration (FDA) is issuing a final rule classifying dental amalgam into class II, reclassifying dental mercury from class I to class II, and designating a special control to support the class II classifications of these two devices, as well as the current class II classification of amalgam alloy. The three devices are now classified in a single regulation. The special control for the devices is a guidance document entitled, "Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy." This action is being taken to establish sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of these devices. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for the devices.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2009/08/04/E9-18447/dental-devices-classification-of-dental-amalgam-reclassification-of-dental-mercury-designation-of)
---
*AI Analytics · CC0 1.0*