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This product will be used by Dental professionals and authorized technicians to clean teeth by means of ultrasonic scaling. It can be placed into any approved 25K Ultrasonic Dental device handpiece on the market.

This devices is for Prescription Use as established by 21 CFR Part 801 Subpart D and it will be sold to the practitioner or through an authorized distributor.

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This document is a 510(k) premarket notification letter from the FDA for a dental device, the "25K Series Insert." It primarily communicates the FDA's determination of substantial equivalence to predicate devices. As such, it does not contain the detailed study information typically found in a clinical trial report or a performance study summary that would include acceptance criteria, device performance data, sample sizes, ground truth establishment, or multi-reader multi-case study results.

Therefore, I cannot extract the requested information from this document. The letter simply states that the device is substantially equivalent for its intended use, which is ultrasonic scaling by dental professionals.

If you have a different document that details the performance study for the 25K Series Insert, please provide it.

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