(170 days)
This unit combines both ultrasonic scaling and airpolishing functions in one compact unit that answers all prophylaxis needs. The air polishing function is intended to be used to remove stubbern stains, plaque and soft debris. The scaler funtions is intended to be used for cauculus removal. Device applications: Routine oral prophylaxis, routine polishing especially in hard to reach fissures and interproximal areas, prior to enamel etching and bonding techiniques and prior to bonding orthodontic bands and brackets.
Jetsonic 2000 combines both ultrasonic scalling and air polishing functions in one compact unt that answers all prophylaxis needs.
I am sorry, but the provided text does not contain any information regarding acceptance criteria or a study that proves the device meets acceptance criteria. The document is a 510(k) summary and FDA clearance letter for a medical device (Jetsonic 2000 Ultrasonic Scaler and Air Polishing Unit). It describes the device, its intended use, and states that it has been found substantially equivalent to a predicate device. However, it does not include details about device performance metrics, clinical studies, sample sizes, expert involvement, or ground truth establishment.
§ 872.6080 Airbrush.
(a)
Identification. An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.(b)
Classification. Class II. The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.”