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Dental casting Type III alloys intended for manufacturing: Crowns Short Span Bridges Inlays

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The provided text is a 510(k) clearance letter from the FDA for a dental alloy device (Starcast Dental Alloys). It is a regulatory document and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the questions asked.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on:

• Device Name: Starcast Dental Alloys
• Regulation Number: 21 CFR 872.3060
• Regulation Name: Gold-based Alloys and Precious Metal Alloys for Clinical Use
• Regulatory Class: II
• Product Code: EJT
• Indications for Use: Dental casting Type III alloys intended for manufacturing: Crowns, Short Span Bridges, Inlays
• FDA Determination: Substantially equivalent to legally marketed predicate devices.
• General Controls: Requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

To answer your questions, I would need a technical study report, a submission summary, or a similar document describing the actual performance testing of the device.

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