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Permanent canal filling

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This document is a marketing clearance letter from the FDA for a medical device (ACROSEAL Root Canal Sealer), not a study report. Therefore, it does not contain any information regarding specific acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies.

The letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to proceed to market. This determination is based on the information provided in the Section 510(k) premarket notification. The letter also lists general regulatory requirements that the manufacturer must follow.

To provide the requested information, you would need to access the actual 510(k) premarket notification submitted by Septodont S.A.S. for ACROSEAL Root Canal Sealer, as that document would contain the details of any testing and performance data relied upon for the substantial equivalence determination.

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