Search Results

Permanent extraoral and intraoral luting of superstructures (incl. Mesostructures) made of metal, ceramics, zirconium dioxide and polymers (composite, hybrid ceramics or PMMA) on prefabricated adhesive/titanium bases (extraorally only), on customized titanium and zirconium dioxide bases (both extraorally and intraorally) as well as on dental hard tissue.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the "Bifix Hybrid Abutment Cement." It acknowledges the device's substantial equivalence to predicate devices and outlines regulatory requirements. However, this document does NOT contain information about acceptance criteria or a study proving that a device meets those criteria.

This document is a regulatory clearance letter for a dental cement, not a medical device that uses AI or requires performance metrics for an algorithm. Therefore, the requested information (acceptance criteria, device performance table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set size, and ground truth establishment for the training set) is not applicable and not available within the provided text.

Ask a specific question about this device