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Fabricating inlays, crowns, bridges, precision milling bars and attachments, and crowns and bridges for porcelain fused to metal technique.

CERA R PLUS ALLOY is a gold-based dental alloy for prosthodontic devices.

The provided text is a 510(k) summary for "CERA R PLUS ALLOY," a gold-based dental alloy. It explicitly states that no specific acceptance criteria or a study demonstrating the device meets such criteria are included in this document because the device relies on substantial equivalence to predicate devices and historical use.

The core argument for the device's safety and effectiveness is based on:

• Similarity to legally marketed dental alloys: "CERA R PLUS ALLOY is very similar in formulation to legally marketed dental alloys."
• Prior use of components: "All of the components found in CERA R PLUS ALLOY have been used in marketed devices."
• Historical use in Europe: "This alloy has been on the European market since 1998 with over 800,000 units placed."

Based on these points, the document states: "Therefore, it was determined that no biocompatibility testing was necessary." This implies that without specific biocompatibility testing or performance studies, there wouldn't be set acceptance criteria for such tests.

Therefore, I cannot provide the requested table and study details because they are not present in the provided document. The document specifically points out that these types of studies were deemed unnecessary due to the device's nature and history.

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