(83 days)
ENIGMA teeth are to be used in conjunction with denture base resin for the construction of full and partial dentures. For use only by or on the order of a dental professional such as DDS or DMD. Not for use by general public or OTC.
Schottlander ENIGMA denture teeth
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for "Enigma Denture Teeth" and does not contain the detailed information required to describe acceptance criteria and a study proving device adherence to these criteria. The document acknowledges FDA's review and determination of substantial equivalence to a predicate device, allowing the product to be marketed.
To answer your request, I would need a document that includes sections on:
- Performance testing results
- Acceptance criteria definitions
- Methodology of studies (e.g., sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods)
- Results of standalone device performance or comparative effectiveness studies.
The provided text focuses on regulatory clearance and indications for use, not the technical study details you are asking for.
§ 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.