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• Intracanal dressing for endodontic treatment of pulp necrosis and retreatments.
• Intracanal dressing in cases of perforations, external and internal resorptions, prior to the use of MTA ANGELUS OR MTA REPAIR HP.
• For the treatment of incomplete root formation (rizogenesis):
  Apexification - the formation of the apex in cases of pulp necrosis;
  Apexigenesis - the formation of the apex in cases of vital pulp.

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The provided text does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is an FDA clearance letter for a dental device called "BIO-C TEMP," which is a root canal filling resin.

The letter primarily covers:

• The FDA's review and determination of substantial equivalence for the device.
• Regulatory information, including general controls, classification, and applicable regulations.
• Contact information for FDA resources.
• The indications for use for the BIO-C TEMP device.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method for a test set.
5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Results of a standalone algorithm performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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