(80 days)
SECURALLOY ™ is a dental amalgam for use in the obturation of the cavities of posterior teeth and building of false stumps.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a dental amalgam device called SECURALLOY™. This document primarily concerns the regulatory approval of the device based on its substantial equivalence to a legally marketed predicate device.
This document DOES NOT contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies.
Therefore, I cannot provide the requested information based solely on this document. The letter only confirms that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent for its stated Indications For Use. The details about the studies conducted to demonstrate this equivalence would typically be found in the original 510(k) submission, not in the clearance letter itself.
§ 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.