(71 days)
Sculpture Plus Nano-Hybrid Composite is an indirect or direct/indirect dental restorative material. It is indicated for use, in cured form, to restore carious lesions or structural defects or lost tooth structure either by itself or in combination of metal/ceramic/polymeric substrates and conditioners such as bonding, luting, etching agents commonly used in tooth restoration. The curing can be processed using photo and/or heat curing devices. The curing can accomplished in air, under vacuum or under pressure without or with inert atmosphere.
Sculpture Plus Nano-Hybrid Composite is an indirect or direct/indirect dental restorative material.
I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The document is a 510(k) summary for a dental restorative material, Sculpture Plus Nano-Hybrid Composite, stating its substantial equivalence to a predicate device. It focuses on regulatory approval based on equivalence, not on performance studies with specific acceptance criteria as you've outlined.
§ 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.