(66 days)
Intended for tooth restorations as a treatment for dental carries and for interious for tooth restorations (Class I and Class II), when other materials or restoration techniques are not indicated. For professional use only.
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I am unable to answer this question. The provided document is a letter from the FDA to SDI Limited regarding the substantial equivalence of their device, Ultracaps S, to legally marketed predicate devices. This letter does not contain information about acceptance criteria, device performance, study design, or expert qualifications, which are necessary to answer the prompt.
§ 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.