(34 days)
ESTELITE FLOW QUICK is a low viscous, light cured hybrid composite dental tooth shade resin material. It is intended for use in various dental procedures, including direct anterior and posterior restorations (particularly for small/shallow/tunnel shaped cavities), as the first layer of direct restorations, blocking out cavity undercuts before fabricating indirect restorations, and repair of porcelain/composite materials.
For use as a tooth shade resin material in dental procedures
ESTELITE FLOW QUICK is a low viscous, light cured hybrid composite dental tooth shade resin material.
The provided text does not contain information about acceptance criteria or a study proving device performance against such criteria for the ESTELITE FLOW QUICK device. The document is a 510(k) summary for a dental resin material, focusing on its intended use, technological characteristics, and substantial equivalence to a predicate device. It confirms FDA clearance based on substantial equivalence, but it does not detail performance studies or acceptance criteria.
Therefore, I cannot provide the requested information.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.