(35 days)
Composite restorative material for: Restorations of type I, II, III, IV, and V cavities (according to Black); Fillings in deciduous teeth; Extended fissure sealing; Cervical erosions and abrasions; Cutting edge build-up; Repairing of veneers made of composite and ceramics; Inlays fabrication; Interlocking of loose teeth
REFERENCE® is classified as a tooth shade resin material (21 C.F.R. § 872.3690) because it is a device composed of methacrylates intended to restore carious lesions or structural defects in teeth. REFERENCE® is a further development based on the experience with PERTAC® II. The material characteristics were improved to obtain better handling and wearing properties. Furthermore, REFERENCE® is able to release fluoride ions.
This request cannot be fulfilled. The document provided for analysis is a 510(k) summary, which concerns devices already on the market and does not contain information about studies proving performance criteria for a novel AI/ML device. The document is for a dental restorative material, not an AI/ML device. Therefore, it is impossible to extract the requested information like expert qualifications, adjudication methods, or MRMC studies, as these concepts are not applicable to the provided content.
§ 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.