(8 days)
Silverfil amalgam is used by dental professionals to fill tooth cavities. It is used in the same way as other amalgams used in the world today. Its usage and handling techniques are the same as other amalgams.
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This document is a 510(k) premarket notification decision letter from the FDA for a dental amalgam alloy. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The document is primarily focused on the declaration of "substantial equivalence" to a predicate device, which is a regulatory pathway for certain medical devices.
Therefore, I cannot provide the requested information as it is not present in the provided text.
§ 872.3070 Dental amalgam, mercury, and amalgam alloy.
(a)
Identification. Dental amalgam is a device that consists of a combination of elemental mercury, supplied as a liquid in bulk, sachet, or predosed capsule form, and amalgam alloy composed primarily of silver, tin, and copper, supplied as a powder in bulk, tablet, or predosed capsule form, for the direct filling of carious lesions or structural defects in teeth. This device also includes the individual component devices, mercury and amalgam alloy, when intended to be combined with each other to form dental amalgam.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy.”See § 872.1(e) for the availability of this guidance document.