(12 days)
Protégé Ultrasonic Inserts, both 25KHz and 30KHz models, are intended to be used in the handpieces of any magnetostrictive ultrasonic scaler for dental cleaning and the removal of tenacious calculus deposits by application of an ultrasonic vibrating tip to the teeth.
Protégé Ultrasonic Insert Devices
The provided document is a 510(k) premarket notification letter from the FDA for dental ultrasonic inserts. This type of document declares substantial equivalence to a predicate device and does not contain the detailed study information regarding acceptance criteria, sample sizes, expert qualifications, or ground truth that would typically be found in a clinical study report or a more comprehensive technical document.
Therefore, I cannot extract the requested information from this document. The document primarily focuses on regulatory approval and does not provide specifics on device performance beyond stating its intended use.
§ 872.4850 Ultrasonic scaler.
(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.