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Willi Geller Creation ZI Porcelain is a ceramic material intended for the veneering of zirconium oxide based cores and substructures to form dental restorations

Williw Geller Creation ZI porcelain is a dental ceramic that is used by dental technicians to fabricate dental restorations by veneering of zirconium oxide-based cores.

This document (K043201) describes a dental porcelain device, not an AI/ML powered medical device. Therefore, the information requested regarding acceptance criteria, study details, ground truth, and AI-specific metrics cannot be extracted.

The document primarily focuses on establishing substantial equivalence for the "Willi Geller Creation ZI Porcelain" with predicate devices based on its mechanical properties, chemical qualities, and indications for use as a dental ceramic for veneering zirconium oxide-based cores.

No information regarding acceptance criteria for an AI/ML powered medical device, study design for performance evaluation, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies is present in the provided text.

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