(83 days)
An air-powered handpiece intended for use in removing dental plaque and stains from teeth by projecting a stream of air, water and sodium bicarbonate onto tooth surfaces. Its use is contraindicated on patients with chronic respiratory disease, renal deficiencies or suffering chronic diarrhea and those on salt-free or salt-limited diet regimens.
Parkell's MODEL MS-2 HANDPIECE is an air-powered handpiece intended for use in removing dental plaque and stains from teeth by projecting a stream of air, water and sodium bicarbonate onto tooth surfaces.
This 510(k) summary describes a dental handpiece, not an AI/ML powered medical device. Therefore, the requested information regarding acceptance criteria, study design, ground truth, and expert involvement is not applicable.
The submission is for the Parkell Model MS-2 Handpiece, an air-powered prophylaxis handpiece intended for removing dental plaque and stains. It is a traditional mechanical device, and its substantial equivalence determination is based on the comparison to a legally marketed predicate device (PROPHYFLEX 2, MODEL 2012), not on clinical performance studies typically associated with AI/ML devices.
The document focuses on the device's intended use, contraindications, and regulatory classification, typical for a 510(k) premarket notification for a Class I mechanical device.
§ 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.