Author: U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health.
Source: Guidance for Industry and FDA Staff
Year: 2009
Comment:
This is FDA's 2009 Final Rule, which was challenged by the IAOMT in a Petition for Reconsideration, leading to the 2010 Dental Products Panel hearings about dental amalgam.
Abstract / Excerpt:
“The Food and Drug Administration (FDA) has developed this guidance as the special control to support the classification of dental amalgam into Class II (special controls), the reclassification of dental mercury1 from Class I to Class II, and the current classification of amalgam alloy in Class II. The three devices are now classified in a single regulation, Dental Amalgam, Mercury, and Amalgam Alloy, 21 CFR 872.3070. Mercury is elemental mercury, supplied as a liquid in bulk, sachet, or predosed capsule form, intended to be combined with amalgam alloy for the direct filling of carious lesions or structural defects in teeth. Amalgam alloy is composed primarily of silver, tin, and copper, supplied as a powder in bulk, tablet, or predosed capsule form, and is intended to be combined with mercury for the direct filling of carious lesions or structural defects in teeth. Dental amalgam consists of a combination of mercury and amalgam alloy, and is intended for the direct filling of carious lesions or structural defects in teeth. FDA is issuing this guidance in conjunction with a Federal Register (FR) notice announcing the final rule classifying dental amalgam, mercury, and amalgam alloy into Class II (special controls). The classification regulation designates this guidance document as the special control for these three devices.”
Citation:
U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health. Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy. Guidance for Industry and FDA Staff. 2009.