(55 days)
These contra-angles are intended.for use. on dental motors equipped with a coupling according to ISO Standard 3964.
The speed of the motors may not exceed 40 000 RPM.
These contra-angles may receive all dental instruments for contra-angles (burs, prophylaxis instruments, endodontic instruments) whose shank is of type 1, such as : determined in ISO Standard 1797.
They allow to carry out all low speed dental works
Their usage is of course reserved to dentists or hygienists who are duly graduated and entitled to exercise.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to MICRO-MEGA SA regarding their Series XE, SE, and TE contra-angles. It acknowledges that the device is substantially equivalent to legally marketed predicate devices.
However, the document does not contain any information about:
- Acceptance criteria or reported device performance for these contra-angles.
- Any study, clinical or otherwise, that proves the device meets specific acceptance criteria.
- Sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
This letter is a regulatory approval document based on substantial equivalence, not a detailed study report. Therefore, I cannot extract the requested information 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.