(55 days)
The JETSTREAM airpolishing unit is intended to be used to remove stubborn stains, plaque and soft debris. Device applications: Routine polishing especially hard to reach areas, polishing prior to enamel etching and bonding techniques and prior to bonding orthodontic bands and brackets
JETSTREAM airpolishing unit
This document is a 510(k) clearance letter from the FDA for a dental device called "JetStream". It does not contain information regarding an acceptance criteria study or performance data, sample sizes, expert qualifications, or ground truth establishment for an AI or imaging device. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and can be marketed.
Therefore, I cannot provide the requested information based on the input document. The document is not related to the type of study described in the prompt.
§ 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.”