(76 days)
A nano-filled, light-cured, clear resin intended for use by a duly licensed professional as a glaze and sealer for composite resin restorations or for acrylic, bis-acryl and/or composite temporary materials. It can be used to impart high sheen and seal to appropriate surfaces without oxygen-inhibition and is expected to extend restoration durability and resistance to abrasive wear. Due to its photo-initiators, it may be cured by all common dental curing lights.
DuraFinish All-Cure is a nano-filled, light-cured, clear a gloza ond now as the use by a duly licensed professional as a glaze and sealer for composite resin restorations or for acrylic, bis-acryl and/or composite temporary materials. It can be used to impart high sheen and seal to appropriate surfaces. Due to its added photo-initiators, it may be cured by any common dental curing light.
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) summary for a dental product called "DuraFinish All-Cure Resin Glaze," detailing its classification, intended use, and substantial equivalence to a predicate device, but it does not include performance data or studies against specific acceptance criteria.
§ 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.