(227 days)
Products intended for professional use only. Used in general dentistry for restoration procedures.
Lares Research Smoothdrive 1:5 contra angle handpiece is intended for professional use only. The device is used in general dentistry for restoration procedures.
The Lares Research Smoothdrive 1:5 contra angle is a high-speed dental handpiece which is driven by an electrical motor. The device is designed to be connected to ISO 3964 compatible electric motors operating between 0 and 40,000 rpm. The device has a 1:5 speed increasing transmission (identified by the industry standard red ring) which translates to a working end speed of 0 to 200,000 rpm. The device has a push button chucking system is designed to allow convenient bur changing for ISO 1797 type 3 burs.
The requested information is not available in the provided text. The document is an FDA 510(k) clearance letter for a dental handpiece, focusing on substantial equivalence to predicate devices rather than detailed performance studies with acceptance criteria, sample sizes, expert ground truth, or comparative effectiveness with AI.
The document states:
- "No clinical field trials have been conducted with the Lares Research Smoothdrive 1:5 contra angle handpiece." (Page 4)
- "Performance tests were conducted in-house at Lares Research with production samples of the Smoothdrive 1:5 contra angle. The contra angle motor connection, speed, sound, temperature and chucking mechanism were all evaluated during validation testing. Validation testing concluded the device meets all of the applicable consensus standards." (Page 4)
Without further details on the "applicable consensus standards" and the specific results of the validation testing, the acceptance criteria and detailed study information cannot be extracted.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria with the provided information.
§ 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.