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For cementation of Temporary Restorations

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This is a 510(k) clearance letter for a medical device (Temporary Cement). The provided document does not contain information regarding acceptance criteria, device performance studies, or details about training and test sets of AI algorithms.

The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It refers to general controls and FDA regulations but does not include any performance data or study design.

Therefore, I cannot extract the information required to answer your questions based on the provided text. This document is a regulatory approval, not a scientific study report.

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