(92 days)
Intended Use:
SR Nexco is intended to be used as follows:
Framework-based
- Veneering of metal-supported restorations .
- Veneering of combination dentures (telescope crown veneers) .
- Veneering of fixed-removable implant superstructures .
- . Veneering of gingiva portions in fixed removable implant superstructures
- Veneering of CAD/CAM fabricated metal frameworks .
- Masking of model cast frameworks with SR Nexco Opaquer Pink .
Framework-Free
- Inlays/Onlays/veneers .
- Anterior Crowns .
Modification/Characterization
- Superficial characterization of Ivoclar Vivadent resin teeth with SR Nexco . Stains in conjunction with SR Connect and subsequent layering with SR Nexco Paste lavering materials
- Shape and shade modifications of Ivoclar Vivadent resin teeth with SR . Nexco Paste layering materials in conjunction with SR Connect
- Modification and characterization of Telio CAD and Telio Lab with SR ● Nexco Stains, Dentin, Incisal and Effect Shades in conjunction with SR Connect.
Not Found
I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) premarket notification approval letter for a dental resin material, SR NEXCO. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI-powered medical device. The document is strictly about the regulatory approval of a tangible dental product.
§ 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.