(192 days)
Unit for cleaning the spray channels and lubricating the moving parts of dental and surgical handpieces, turbines, air motors and air-driven dental scalers.
The W&H Assistina TWIN MB-302 is an electrically and pneumatically driven maintenance device with the following functions:
- Rinsing the spray channels with cleaning solution (water basis) and drying with compressed air.
- Lubricating the rotational internal gear parts. The oil is spread and a constant lubrication film is set up.
The provided text describes the W&H Assistina TWIN MB-302, a device for cleaning and lubricating dental and surgical handpieces. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of acceptance criteria and performance against those criteria.
Therefore, the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert involvement, adjudication, MRMC studies, standalone performance, ground truth), and training set information is not available in the provided text.
The closest information provided related to performance or testing is under the "Performance Testing" section (page 6), which lists various tests performed to demonstrate safety and effectiveness:
- Electrical Safety Tests according to IEC 61010-1
- Electromagnetic Compatibility Test according to IEC 61326-1
- Software validation according to IEC 62304:2006
- Biological Assessment and Cytotoxicity Testing of the liquids according to EN ISO 10993
- Risk Analysis according to ISO 14971
- Testing of cleaning performance according to ISO 15883
- Validation of wipe disinfection according to the IFU
- Bench Tests like Lifetime tests (Activation of start button, moving/removing of sliding door, Lifecycle test)
However, specific acceptance criteria values and the reported performance against these criteria are not detailed. The text only states that the results "demonstrate substantial equivalence" and that the biological assessment "meets the requirements," without specifying what those requirements are or the numerical results achieved. It also explicitly states "Clinical Testing: Not applicable," indicating that no clinical studies were performed.
§ 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.