(292 days)
The Elite low speed air motor with Elite "E" contra-angle is to power various attachments which helps the dental clinician perform various dental procedures, removing carious material and excess filling material, cavity and crown preparation, root canal preparations, restoration and polishing teeth.
The Medidental high speed handpiece is an air-powered dental handpiece which helps the dental clinician perform various dental procedures such as removing carious material and excess filling material, cavity and crown preparation, root canal preparations, restoration and polishing teeth.
The Elite low speed air motor with Elite "E" contra-angle is to power various attachments which helps the dental clinician perform various dental procedures, removing carious material and excess filling material, cavity and crown preparation, root canal preparations, restoration and polishing teeth.
The Medidental high speed handpiece is an air-powered dental handpiece which helps the dental clinician perform various dental procedures such as removing carious material and excess filling material, cavity and crown preparation, root canal preparations, restoration and polishing teeth.
This is a 510(k) premarket notification for a dental handpiece, not an AI/ML medical device. Therefore, the requested information about acceptance criteria, study details, expert involvement, MRMC study, standalone performance, ground truth, and training set is not applicable.
The provided document describes the substantial equivalence determination for:
- Trade Name: Elite Low Speed Air Motor with Elite "E" Contra-angle, Medidental High Speed Handpiece
- Common Name: Air-powered Low Speed Handpiece, E Type contra-angle, Air-powered High Speed Handpiece
- Classification Name: Handpiece, Air-Powered Dental
- Product Code: EFB (later listed as EFA in the FDA letter, which could be a typo or an update)
The device is intended to power various attachments for dental procedures such as removing carious material, excess filling material, cavity and crown preparation, root canal preparations, restoration, and polishing teeth.
The device was found substantially equivalent to the predicate device:
- Predicate Device: High & Low Speed Handpiece, with E-Type contra-angle (K073652) manufactured by NAKAMURA MAGNIFIER CO., LTD.
The FDA's review for such devices typically focuses on comparing the new device's technological characteristics and performance to a legally marketed predicate device to ensure it is as safe and effective. This generally involves mechanical and performance testing relevant to its function as a dental handpiece, such as speed, torque, vibration, noise, and compatibility with attachments, but not AI/ML-specific metrics.
§ 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.