(256 days)
The DELSONIC 2000 Ultrasonic Scaler is intended to be used fast and reliable removal of light to heavy calculus and plaque. This 29kHz ultrasonic system provides automatic tuning for each scaling insert.
The DELSONIC 2000 is an automatically tuned piezo ultrasonic scaler that generates linear tip movement at 29kHz for efficient, yet gentle calculus removal. The DELSONIC piezo ultrasonic scaler is designed for the prevention of crossinfection with fully autoclavable handpiece sleeves sterlisible removable control knobs and wipe clean display panel
The provided text is a 510(k) summary for the Delsonic 2000 Ultrasonic Scaler. It does not contain information about acceptance criteria, device performance, or any studies proving the device meets acceptance criteria.
The document is a submission to the FDA for market clearance, stating the device's substantial equivalence to a predicate device (Dentsply). It describes the device, its intended use, and its classification. The subsequent pages are the FDA's response letter granting market clearance.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided text. The requested information is not present in this document.
§ 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.