(70 days)
belleGlaze is designed to be used to enhance the surface finish of the polished belleGlass restoration. It will impart a porcelain-like glaze on all surfaces, especially on posterior occlusial surfaces.
The device is a resin-based, dental restorative glaze which is used to coat belleGlass restorations to give them a porcelain-like, shiny surface, especially on posterior occlusial surfaces.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document appears to be a 510(k) summary for a dental restorative glaze ("belleGlaze") and a letter from the FDA determining substantial equivalence to a predicate device.
The document focuses on:
- Device Name and Classification
- Predicate Devices
- Device Description
- Intended Use
- A statement of Substantial Equivalence
- FDA's letter confirming the 510(k) clearance
There is no mention of performance metrics, study design, sample sizes, expert involvement, or ground truth establishment. Therefore, I cannot extract 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.