(84 days)
Vita Enamic® Stains are indicated for shade customization and characterization of the surface of dental restorations made of hybrid ceramic-resin and resin materials.
The Vita Enamic 6 Stains are color Intensive resins used for shade characterization of the The Vita Enamic restorations made from Vita Enamic The shades are supplied in sonder form. This powder is mixed with a liquid and applied in a very thin layer to an Enamic restoration to adjust the shade or create characteristics found in natural teeth, such as cracks, restoration to of the painted restoration is then sealed with a dear light-curing allaze to create a smooth and glossy finish that is resistant to abrasion. The Stains are a dual curing create a sinopon one phymenzation that is prepared outside the mouth.
This document is a 510(k) summary for "Vita Enamic® Stains". It describes the device and its intended use, and states that it is substantially equivalent to predicate devices. However, it explicitly states there was no clinical performane data or non-clinical performance data done for the device because the device is "for esthetic purposes only". Therefore, none of the requested information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC study, standalone performance, training set details) can be extracted from this document as no such study was conducted or reported.
Specifically, the section "Summary of Non-Clinical Performance Data" on page 1 states: "The intended use of the device is for esthetic purposes only. For this reason, performance Data was not pursued."
Therefore, I cannot provide the requested information.
§ 872.3310 Coating material for resin fillings.
(a)
Identification. A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.(b)
Classification. Class II.