(74 days)
The Prophy-Mate device is intended for use in dental applications to remove stains and plaque deposits from the teeth by shooting a mixture of sodium bicarbonate powers, air, and water onto tooth surfaces.
This product should not be used on patients who are restricted of salt intake (hypernatremia, toxemia of pregnancy); or with critical ulcers in digestive organs, dyshepatia, cardial or lung dysfunction, damage or abnormality in a mouth, congestion, bleeding or inflammation in a mouth, contact lenses, or allergies; or who tend to have inflammation or soreness in the in the oral mucous membrane.
The Prophy-Mate device is intended for use in dental applications to remove stains and plaque deposits from the teeth by shooting a mixture of sodium bicarbonate powers, air, and water onto tooth surfaces.
The provided text is a 510(k) clearance letter from the FDA for a dental handpiece, the Prophy-Mate. It primarily focuses on the regulatory approval process, stating that the device is substantially equivalent to legally marketed predicate devices.
However, this document does NOT contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or any of the other details requested in your prompt.
The letter is a regulatory document, not a scientific study report. It confirms that the device can be legally marketed based on its equivalence to existing products, but it does not describe the specific testing or data used to demonstrate that equivalence in the way you've asked for.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from 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.