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Used in the manufacture of dental prosthetics: crowns, bridges, inlays, and onlays.

Xceram® is a pre-formed material for use by dental laboratories in filling orders/prescriptions for dental prosthetics

The provided text does not contain information about studies proving that the "Xceram®" device meets specific acceptance criteria.

Instead, the document is a 510(k) summary for a dental material where the claim of substantial equivalence to predicate devices is based on:

• Comparisons of formulations
• Mechanical characteristics
• Intended uses
• Identification of porcelain powders in 21 CFR 872.6660

Therefore, I cannot fulfill your request for the tables and details regarding acceptance criteria and a study proving their fulfillment. The section "Performance Data" explicitly states "None required" and explains the basis for substantial equivalence without referencing a performance study or acceptance criteria in the context of device performance.

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