Ultrasonic dental scaler超声波洁牙机 FDA
CFR - Code of Federal Regulations Title 21
PART 872 -- DENTAL DEVICES
Subpart E - Surgical Devices
Sec. 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.