(89 days)
Prelude One is a light cured adhesive designed for direct restorations, i.e. composites and compomers to enamel and/or dentin, composite repairs, porcelain repairs and post and core build-up materials, and indirect restorations such as veneers, onlays, inlays, crowns and bridges.
Prelude One is a dental bonding agent used to restore all classes of cavities
The provided text does not contain information about the acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) summary for a dental bonding agent (Prelude One) and primarily focuses on its substantial equivalence to predicate devices, intended use, and regulatory classification. It does not include details about device performance tests, clinical studies, or specific acceptance criteria.
Therefore, I cannot provide the requested information in the table or answer the specific questions about studies, sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided text.
§ 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.