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Porcelain - to - metal restorations

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The provided text is a 510(k) premarket notification letter from the FDA regarding a dental device called "XeraFit." This document does not contain any information about acceptance criteria or a study that proves the device meets acceptance criteria.

The letter is a regulatory approval document confirming that the device is substantially equivalent to legally marketed predicate devices. It discusses:

• Device Name: XeraFit
• Regulation Number and Name: 872.3710, Base Metal Alloy
• Product Code: EJH
• Intended Use: Porcelain-to-metal restorations
• Regulatory Class: II

The document focuses on the administrative aspects of FDA clearance, such as substantial equivalence, regulatory compliance, and contact information for further inquiries. It does not include technical specifications, performance metrics, study designs, or results from any performance testing.

Therefore, I cannot provide the requested information from this document.

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