(77 days)
MICROFILL 13 is to be used as a filling material for restoring function to teeth that have lost portions due to caries: Direct, fixed restorations, placed by the dentist after removal of carious tissue. Anterior restorations, Class III, IV and V Corrections of anomalies such as peg shaped teeth Splinting of mobile anterior teeth. Repair of resin and ceramic veneers. Reconstruction of anterior trauma cases Veneering of discolored anterior teeth
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The provided text describes a 510(k) premarket notification for a dental device called "Microfill 13." However, it is a regulatory document and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information about the study design elements you asked for. The document solely focuses on the FDA's determination of substantial equivalence to a legally marketed predicate device, allowing "Microfill 13" to be marketed.
§ 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.