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For use to stimulate the healing process due to the mixture of calcium hydroxide and iodoform and the induction effect of these two ingredients. Used to promote healing effects and to help prevent bacterial contamination of the canal, as the two ingredients improve the induction effect for hard tissue induction and deposition. To be used as a medicament for the treatment of infected root canals, and as a permanent, low volume additive to the filling process of a treated root canal to assist in the induction and deposition of hard tissue to make the healing process more rapid and complete. For use in the treatment of infected root canals, or following pulpectomy, or for apexegenesis or apexification, and / or for the tip filling of prepared, treated root canals at the time of final filling with gutta-percha.

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I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental product called "Vitapex Pre-Loaded Dental Syringe" and "NeoDental Vitapex Paste". It states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information.

The document does not contain any of the information requested in your prompt regarding:

• Acceptance criteria table and reported device performance
• Sample size and data provenance for a test set
• Number and qualifications of experts for ground truth
• Adjudication method for a test set
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study
• Standalone (algorithm only) performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

Therefore, I cannot fulfill your request based on the provided input.

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