(50 days)
Silver based alloy dental restorative used in all classes of restorations.
PLA-96P Admix Alloy
This document is a 510(k) clearance letter from the FDA for a dental restorative material named PLA-96P Admix Alloy. It states that the device is substantially equivalent to legally marketed predicate devices.
However, the letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or specific study results. This type of information is typically found in the 510(k) submission itself, which is not provided here.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided document. The document only confirms the FDA's decision regarding substantial equivalence.
§ 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.