Search Results

Fabrication of Dental Crowns, Bridges, Inlays and Low-fusing Porcelain-fused-to-metal Applications.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a dental device named "Pagalinor 4". It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance metrics, or details of a study used to prove the device meets specific criteria.

The letter focuses on regulatory approval based on "substantial equivalence" rather than specific performance data from a clinical or technical study designed to evaluate and report against detailed acceptance criteria.

Therefore, I cannot provide the requested information from the given text. The document is a regulatory approval notice, not a study report.

Ask a specific question about this device