(94 days)
SR Phonares NHC denture teeth are intended to be used for complete and partial denture prosthetics including hybrid dentures and implant-supported dentures.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA to Ivoclar Vivadent, Incorporated, for a dental device called "SR PHONARES NHC," which is a preformed plastic denture tooth. This document does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.
The letter is a regulatory approval document stating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It discusses general control provisions, regulatory classifications, and reporting requirements, but it does not detail any performance studies, test results, or acceptance criteria the manufacturer may have used to demonstrate substantial equivalence to the FDA.
Therefore, I cannot provide the requested information based on the given input.
§ 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.