(104 days)
The A-dec/W&H Synea Profin reciprocating contra-angle handpiece attachment is intended for use in removing protrusions or excess of filling materials and cements, preparation, finishing and polishing in the interdental and subgingival regions, stripping, vibrating of inlays using Dentatus tips and root canal preparations using endodontic files.
Not Found
I am sorry, but the provided text does not contain any information about acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or specific study designs (like MRMC or standalone performance).
The document is a 510(k) premarket notification letter from the FDA to A-dec, Incorporated, regarding a dental handpiece attachment. It primarily confirms the substantial equivalence of the device to legally marketed predicate devices and outlines regulatory compliance requirements.
Therefore, I cannot fulfill your request for the detailed study information as it is not present in the given 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.