(84 days)
Futurabond DC/Single Dose is intended for direct self- or dual curing composite restaurations and core build-ups, direct light-curing composite/compomer/ormocer-based restaurations, fixing root pins/posts with dual- or self-curing composite cements, indirect restaurations with the application of dual-curing composite cements for bonding inlays, onlays, crowns and bridges.
Not Found
The provided text is an FDA 510(k) clearance letter for a dental bonding agent (Futurabond DC/Single Dose). It states that the device is substantially equivalent to a legally marketed predicate device but does not contain any information regarding specific acceptance criteria, study details, performance data, or ground truth establishment.
Therefore, I cannot answer your specific questions about acceptance criteria and the study that proves the device meets them because the information is not present in the provided document. The letter only confirms that the device has received 510(k) clearance based on substantial equivalence, implying that the manufacturer conducted studies to demonstrate this equivalence, but the details of those studies are not included in this FDA correspondence.
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.