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• temporary cementing of temporary crowns and bridges
• temporary cementing of final restorations

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I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and the study proving the device meets those criteria.

The document is a 510(k) premarket notification letter from the FDA to Coltene/Whaledent AG regarding their device, TempoSil. It confirms that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use (temporary cementing of temporary crowns and bridges, and temporary cementing of final restorations).

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Information about specific studies conducted, sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
• Details about multi-reader multi-case comparative effectiveness studies or standalone algorithm performance.

The letter primarily focuses on regulatory approval based on "substantial equivalence" rather than presenting detailed study results.

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