(78 days)
The Prophy Star 3 Hygiene Handpiece is a low speed, pneumatically driven, hand-held device intended for use by trained dental professionals for performing dental prophylaxis.
The prophy handpiece is used by trained dental professionals to perform dental prophylaxis.
The Prophy Star 3 Hygiene Handpiece is a low speed, pneumatically driven, hand-held device intended for use by trained dental professionals for performing dental prophylaxis. The handpiece uses either an ISO standard Doriot style reusable Prophy angle or a ISO standard Doriot style disposable angle. The Prophy Star 3 Hygiene Handpiece is a Lube Free handpiece requiring no lubrication.
The provided text describes a 510(k) premarket notification for a dental handpiece, the Prophy Star 3 Hygiene Handpiece. It focuses on establishing substantial equivalence to a predicate device based on intended use, technology, and design.
However, the document does not contain information related to acceptance criteria, a specific study proving device performance against acceptance criteria, or any of the detailed aspects of a clinical or performance study as requested in the input.
Therefore, I cannot provide the requested table and detailed information about acceptance criteria and study particulars for the Prophy Star 3 Hygiene Handpiece based on the given text.
The document is a regulatory approval letter from the FDA (June 15, 2007) and a 510(k) summary (May 21, 2007). These types of documents typically attest to substantial equivalence based on comparisons to existing devices and adherence to general safety and performance standards, rather than presenting detailed multi-reader multi-case studies or standalone algorithm performance data.
Here's what I can infer from the available information, but it does not address the specific questions about acceptance criteria or a dedicated performance study:
- Device: Prophy Star 3 Hygiene Handpiece
- Intended Use: For use by trained dental professionals for performing dental prophylaxis.
- Predicate Device: StarDental Prophy Star II Hygiene Handpiece Micro Motors PHP 100 Prophy Handpiece (K896877)
- Basis for Substantial Equivalence: Same intended use, similar technology and design, same means of operation, and used for the same procedures. Improvements were made to enhance handpiece performance while maintaining safety. This implies that the new device is expected to perform at least as well as the predicate device.
Without a performance study or clinical trial section in the provided text, I cannot answer the specific quantitative questions.
§ 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.