(41 days)
Flowable Hybrid is used for Class V restorations, small occlusal restorations, to seal margins, to repair pitted areas in restorations, as a pit and fissure sealant, to repair marginal defects, for bonding of fibrous splints and for direct resin veneers.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a dental device called "Flowable Hybrid". This document establishes that the device is substantially equivalent to legally marketed predicate devices and outlines its indications for use.
However, this document does NOT contain information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment for AI/ML-based device development.
The letter is a regulatory approval for a physical dental product (Flowable Hybrid) based on its equivalence to existing products, not an AI/ML device that would require detailed performance metrics from a study as typically outlined in your request.
Therefore, I cannot provide the requested information based on the content of this document.
§ 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.