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The Meisinger Benex Tooth Extraction device is to be used to extract teeth and tooth roots when traditional forceps extraction is not possible or when tooth luxation trauma to the alveolar bone is to be kept to a minimum.

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The provided text is a 510(k) premarket notification letter from the FDA for a dental hand instrument called “Meisinger Benex.” This type of documentation is for establishing substantial equivalence to a predicate device and does not typically include detailed information about clinical studies with acceptance criteria, performance metrics, ground truth, or expert involvement in the way an AI/ML device submission would.

Therefore, the provided document does not contain the information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert involvement, or ground truth for proving device performance.

This document confirms the device's classification, outlines general regulatory requirements, and states its intended use, but it doesn't present data from a clinical or performance study in the format requested.

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