(259 days)
The ART-IM1 Implantor is an implant machine system. It is primarily used by dental professionals in doing oral implant surgery or implantology such as drilling, reaming, cutting, etc. This system is also used for fixing previous broken or failed implant procedure.
BonartART-IM1 Implantor System & Accessories
The provided text describes a 510(k) premarket notification for a dental implant machine system, the BonartART-IM1 Implantor System & Accessories. It establishes substantial equivalence to a predicate device based on its indications for use.
However, the document is a regulatory approval letter and an indication for use statement. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the detailed study parameters requested in your prompt.
Therefore, I cannot populate the requested information from the provided text. The document is concerned with regulatory approval based on substantial equivalence, not a detailed performance study as would be seen for AI/ML devices or novel diagnostic tools.
§ 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.