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Dental Devices - Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation of Special Controls for Dental Amalgam (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library

Dental Devices - Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation of Special Controls for Dental Amalgam (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Dental Devices - Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation of Special Controls for Dental Amalgam (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 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. This book contains: - The complete text of the Dental Devices - Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation of Special Controls for Dental Amalgam (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section