(65 days)
The TCM Endo III is an AC-powdered endodontic unit consisting of a controller console, foot pedal and motor intended to drive dental handpieces during root canal preparation.
The TCM Endo III is an AC-powdered endodontic unit consisting of a controller console, foot pedal and motor intended to drive dental handpieces during root canal preparation. The motor has a maximum 1:1 drive output of 16,000 Rpm's. The unit is supplied with either a 115V or 230V power cord. The entire motor assembly of the TCM Endo III is autoclavable.
The provided text is a 510(k) summary for the TCM Endo III, an AC-powered dental handpiece. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert involvement that would be required to answer the specific questions posed.
Therefore, I cannot provide the requested information from the given text. The document is a regulatory submission for market clearance based on substantial equivalence, not a performance study report.
§ 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.