(9 days)
UNIVERSAL NANO-CERAMIC™ RESTORATIVE is indicated for direct restorations of all cavity classes in anterior and posterior teeth.
The UNIVERSAL NANO-CERAMIC™ RESTORATIVE is a light-cured, radiopaque, dental restorative product for use in both anterior and posterior applications. UNIVERSAL NANO-CERAMIC" RESTORATIVE combines nanotechnology with organically modified ceramic particles resulting in a nano-ceramic restorative.
The product's Natural-Shade™ system provides two shading systems in one product. The single translucency system offers seven shades of intermediate translucency while the double translucency system offers four dentin shades with natural dentin translucencies and three enamel shades which emulate natural enamel.
UNIVERSAL NANO-CERAMIC™ RESTORATIVE is composed of resin monomers, pigments, stabilizers, fillers, a fluorescing agent, activator, and accelerator.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted on the "UNIVERSAL NANO-CERAMIC™ RESTORATIVE" device. The document is a 510(k) summary for a dental restorative product, primarily focusing on its description, intended use, and substantial equivalence to predicate devices, but it does not detail any performance studies with specific statistical data or methodology.
Therefore, I cannot provide the requested table or answer the questions regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance.
§ 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.