(21 days)
The Zen Cordless Prophy System is a high-performance cordless prophylaxis handpiece with a wireless foot pedal for use with Zen's disposable prophylaxis angles to clean and polish teeth.
The Zen Cordless Prophy System is a high-performance cordless prophylaxis handpiece with a wireless foot pedal for use with Zen's disposable prophylaxis angles to clean and polish teeth.
This document is a 510(k) clearance letter from the FDA for a dental handpiece (Zen Cordless Prophy System). It states that the device is substantially equivalent to legally marketed predicate devices.
The information requested in the prompt (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in this document. This letter and its enclosure ("Indications for Use Statement") only confirm FDA clearance and describe the intended use of the device. It does not contain any details about performance studies or acceptance criteria.
Therefore, I cannot provide the requested table or answer the specific questions based on the provided text.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.