(84 days)
BeautiBond is a light-cured single-component dental adhesive intended to bond dental filling material to cavity or lesion including dentin or enamel for filling restorations of both anterior and posterior teeth.
BeautiBond is a light-cured single-component dental adhesive.
The provided text is a 510(k) premarket notification letter from the FDA regarding a dental adhesive named "BeautiBond." It confirms the device is substantially equivalent to legally marketed predicate devices and outlines regulatory compliance.
However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other details of a study based on the provided text. The document is solely an FDA clearance letter, not a study report.
§ 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.