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CERCON® BASE is indicated for crowns, multi-unit bridges, and inlay bridges. Applications include both anterior and posterior regions.

CERCON® BASE is a dense ceramic composed of partially sintered yttria stabilized zirconia powder (1-TZP). It is processed in the dental laboratory by machining from a partially sintered 1-TZP blank which is then sintered to near full density and finally veneered with a dental veneering ceramic. It is designated as a substructure (framework) for single tooth or bridge type restorations. CERCON® BASE is similar to other 1-TZP products currently in the market.

The provided text is a 510(k) summary for the CERCON® BASE dental material, which is a partially sintered yttria-stabilized zirconia powder used for crown and bridge restorations. It describes the device, its intended use, and technological characteristics compared to a predicate device.

However, the document does not contain any information about acceptance criteria, a study proving the device meets these criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Therefore, I cannot provide the requested information. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on material composition and intended use, rather than specific performance metrics or clinical study results as you've requested.

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Cercon Base is a partially sintered yttria (yttrium oxide) stabilized zirconia (zirconium oxide) powder that is machined and then sintered to full density. It is designed for use as a substructure (framework) for single tooth or bridge type restorations. Applications include both anterior and posterior locations.

Cercon Base is a partially sintered yttria (yttrium oxide) stabilized zirconia (zirconium oxide) powder that is machined and then sintered to full density.

I am sorry, but based on the provided text, I cannot extract any information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA regarding a dental ceramic device named "Cercon Base." It primarily discusses the regulatory approval process, classification, and general compliance requirements for marketing the device. There is no mention of specific acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.

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