(279 days)
The PRO M CLASS is used by dental professionals for orthodontic procedures using a root canal instrument and tightening and loosening an abutment screw to fix and remove the abutment on a dental implant in prosthodontic treatment.
The PRO M CLASS is an AC-powered device that includes a 'Motor Handpiece', 'Contra angle Handpiece', 'Charger unit' and 'AC/DC Adaptor' for grinding, cutting, polishing and screw driver work in dental oral use. The PRO M CLASS uses the battery inside the motor handpiece as a power source to rotate the micromotor to transmit the generated rotational power to the contra angle. Dental treatment is performed using the rotational power obtained by this. The motor turned by the power converted into DC 5.0V by controller delivers its turning power to the file through spin to perform punching, cutting and removing functions. The hand-piece can be operated, stopped and set/adjusted on/in its speed, torque and turning direction by handling of the controller.
This document is a 510(k) K213897 clearance letter for the Saeyang Microtech Co., Ltd. PRO M CLASS dental handpiece. It asserts substantial equivalence to a predicate device and reference devices but does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document focuses on regulatory compliance and comparison to previously cleared devices. Therefore, the requested information cannot be extracted 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.