(62 days)
Silver based alloy dental restorative used in all classes of restorations.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a dental restorative material, "Benco Spherical." This document confirms the device's substantial equivalence to a predicate device and permits its marketing. It does not contain information about acceptance criteria, device performance studies, or details relevant to the specific questions posed (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details). These types of details are typically found in the 510(k) submission itself, which is not provided here, rather than in the FDA's decision letter.
Therefore, I cannot provide the requested information based solely on the provided text. The document is a regulatory approval letter, not a technical report on device performance.
§ 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.