(108 days)
The intended use of the Air Schic Scaler is intended for use by dental professionals during dental cleaning and periodontal therapy to remove calculus and tartar deposits from teeth.
The Air Sonic Scaler, is intended for use by medical professionals during cleaning and periodontal therapy to remove calculus and tartar deposits and stains from teeth using the application of an ultrasonically vibrating frequency through a surgical 440A stainless steel tip, The tip comes in 3 different shapes (AS1, AS2, AS3) and is designed to generate a vibrating frequency of 6,000 Hz.
The provided document is a 510(k) premarket notification for an Air Sonic Scaler. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The document primarily focuses on establishing substantial equivalence to a predicate device and regulatory compliance.
Therefore, I cannot provide the requested information based on the given text. The text does not detail any performance studies, test sets, expert involvement, adjudication methods, or specific ground truths for evaluating the Air Sonic Scaler's performance against defined acceptance criteria.
§ 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.