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Fabrication or repair of bases for partial or full dentures.

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The provided document is a 510(k) clearance letter from the FDA for a device named "THE.R.MO.FREE" used for the "Fabrication or repair of bases for partial or full dentures."

However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory clearance letter based on substantial equivalence to a predicate device, not a performance study report.

Therefore, I cannot provide the requested information from this document. The sections you asked for (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) are typically found in clinical study reports or comprehensive device testing summaries, which are not part of this 510(k) clearance letter.

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Fabrication of dental prostheses like: clasps on partial prostheses, provisional bridges, space maintainers, partials, active and passive aesthetic containing devices, and gnatological bites.

Acetal Dental / Preformed Clasp

This document is a 510(k) clearance letter from the FDA for a dental device (Acetal/Dental Preformed Clasp). It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methods.

Therefore, I cannot provide the requested information based on the provided text. The letter only confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed. It details regulatory information and responsibilities but not the technical data supporting the clearance.

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