(66 days)
Nanofilled, semi anatomical plastic teeth composed of polymethylmethacrylate intended for use as teeth in full or partial dentures.
Nanofilled, semi anatomical plastic teeth composed of polymethylmethacrylate
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental device called CONDYLOFORM II NFC. This document details the regulatory approval process and includes the indications for use for the device.
However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or any of the other specific details you are asking for regarding a study proving the device meets acceptance criteria.
Therefore, I cannot provide the requested information based on the input text.
§ 872.3590 Preformed plastic denture tooth.
(a)
Identification. A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.