Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy

The Food and Drug Administration (FDA) is proposing three actions that will provide consistent regulation of dental mercury and dental amalgam products. FDA is proposing to issue a separate classification regulation for encapsulated amalgam alloy and dental mercury, a preamendments device, intended to be mixed in a singleuse capsule to form filling material for the treatment of dental caries as class II (special controls); to amend the classification for amalgam alloy, a class II preamendments device, by adding special controls; and to reclassify from class I (general controls) to class II the preamendments device dental mercury intended for use as a component of amalgam alloy in the restoration of a dental cavity or broken tooth. These actions are being taken because the agency believes that there is sufficient information to establish special controls that will provide reasonable assurance of the safety and effectiveness of these devices. Elsewhere in this issue of the Federal Register, FDA is announcing the availability for comment of a draft guidance document that is proposed as a special control. DATES: Submit written or electronic comments by May 21, 2002. See section XI of this document for the proposed effective date of a final rule based on this document. ADDRESSES: Submit written comments to the Dockets Management Branch (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20057. Submit electronic comments to http:// www.fda.gov/dockets/ecomments.