(62 days)
Direct anterior/posterior restorations and veneers. Core build ups. Indirect inlays, onlays and veneers. Splinting. Composite and porcelain repair. Sandwich technique with glass ionomers. For professional use only.
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This document is a 510(k) premarket notification letter from the FDA regarding a dental device called "Aura." It indicates that the device has been found substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information about acceptance criteria for the device's performance, the results of any studies demonstrating the device meets such criteria, or details regarding study design, sample sizes, expert involvement, or adjudication methods.
Therefore, I cannot provide the requested table and study details. The document primarily focuses on regulatory approval based on substantial equivalence, rather than detailed performance study results.
§ 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.