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Dental casting alloy for making dental restorations and appliances.
FOR USE WITH DENTAL PORCELAIN NOT (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division ! 510(k) Number
Prescription Use er 21 CFR 801.109)
OR
Over-The-Counter Use ------

High gold casting alloy

This report is a 510(k) summary for a dental casting alloy, not a study evaluating an AI/ML powered device. Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth is not applicable.

However, I can extract information related to the comparison of the new device to a legally marketed predicate device, which can be seen as an analog to "acceptance criteria" for demonstrating substantial equivalence based on physical and chemical properties.

Here's the relevant information:

1. A table of acceptance criteria and the reported device performance

For a 510(k) submission, the "acceptance criteria" for a new device like "Aurecast Bio 69PF" are demonstrating substantial equivalence to a legally marketed predicate device ("Jelenko Benchmark IV"). This is achieved by showing comparable composition and physical/mechanical properties. The tables below outline these comparisons.

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