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Scorpion ultrasonic scaling inserts are used by dental professionals during dental cleaning procedures to remove supragingival calculus deposits from the teeth.

The Scorpion ultrasonic scaling inserts are used by dental professionals during dental cleaning procedures to remove supragingival calculus deposits from teeth by application viennia. vienning. Scorpion manufactures several kinds of ultrasonic scaling inserts adaptable on different vitrasonic scalers. This notification concerns two inserts adaptable on piezo-electric scalers as follows: - BSA scaling insert, adaptable on SATELEC scalers handpieces. - BEM scaling insert, adaptable on EMS scalers handpieces. The Scorpion ultrasonic inserts have essentially the same internal design as the predicate devices.

This document is a 510(k) summary for " tradicionales ultrasonic scaling inserts" and does not contain information about acceptance criteria or a study proving the device meets those criteria. The provided text is a regulatory submission for premarket notification, focusing on the equivalence to legally marketed predicate devices, indications for use, and regulatory classification.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth, or expert qualifications from the given input.

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