(79 days)
Physiostar NFC denture teeth are intended to be used for complete and partial denture r nyslostar NF & dontare tooling and implant-supported dentures.
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I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification letter from the FDA to Candulor USA, Incorporated, regarding their Physiostar NFC device, which is a preformed plastic denture tooth.
The letter confirms the FDA's determination of substantial equivalence for the device based on its intended use, but it does not detail any performance studies, acceptance criteria, or specific performance metrics of the device itself. It mainly focuses on regulatory aspects and compliance requirements.
§ 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.