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Jewel Cast Plus is a dental alloy that is designed for use as crowns, bridges and substrate for high expansion low fusing dental porcelains and indirect composites.

Jewel Cast Plus is a dental alloy that is designed for use as crowns, bridges and substrate for high expansion low fusing dental porcelains and indirect composites. Jewel Cast Plus is substantially equivalent to Pentron Laboratory Technologies, LLC., Jewel Cast III with the exception of an element. However, addition of an element does not affect safety and effectiveness because it dramatically improves the corrosion resistance of the alloy. Also, Molybdenum has been used successfully in dental alloys for over 30 years.

This document is a 510(k) summary for a dental alloy, Jewel Cast Plus. It states that the device is substantially equivalent to a predicate device, Jewel Cast III, with the exception of an added element (Molybdenum) to improve corrosion resistance. However, it does not contain the detailed study information or acceptance criteria you've requested.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, data provenance, ground truth establishment, or expert involvement in a study, as this information is not present in the provided text.

The text solely focuses on the substantial equivalence determination for a dental alloy based on its composition and an assertion regarding its improved corrosion resistance, rather than detailing a performance study with specific acceptance criteria.

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