(4 days)
VarseoSmile Crown plus is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The VarseoSmile Crown Plus material is used for fabricating permanent restorations such as inlays, onlays, veneers and full crown restorations.
VarseoSmile Crown plus is a light-cured, methacrylate-based resin used in 3D printers for the production of permanent crowns, inlays, onlays and veneers. The Subject device is used by a dentist or dental technician for the CAD/CAM manufacturing of permanent dental restorations such as inlays, onlays, veneers and full crown prosthetics in compatible 3Dprinters. Restorations fabricated using the Subject device are one-time use, permanent, prescription-only devices. VarseoSmile Crown is suitable for restoration of occlusal surfaces. VarseoSmile Crown is cured externally to the patient by light sources within a 3D printer and post-curing device. The Subject device is a viscous solution consisting of methacrylate-based resins, dental glass filler, photo initiators and pigments. Commonly used dental CAD software is used by dental professionals to virtually design a fixed indirect restoration and generate an industry-standard "STL" 3D dataset which reflects the intended shape and contour. The Subject resin is used within a validated manufacturing workflow to create the intended restoration. The Subject device is available in a variety of optional shades to reproduce the intended tooth shade of the restoration.
This document is for a dental material (VarseoSmile Crown Plus), not an AI/ML powered medical device. Therefore, a table of acceptance criteria and reported device performance for an AI/ML device, as well as the other requested information related to AI/ML device studies (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance), are not applicable to the provided text.
The information provided focuses on demonstrating substantial equivalence of the dental material to predicate devices based on indications for use, technological characteristics, and non-clinical performance testing against established ISO standards for dental materials.
Here's a breakdown of the relevant information from the document regarding the device's acceptance criteria and how it was shown to meet them:
Acceptance Criteria and Reported Device Performance (Non-AI/ML Device):
| Parameter | Acceptance Criteria (ISO Standard) | Reported Device Performance (VarseoSmile Crown Plus) |
|---|---|---|
| Flexural Strength | ISO 4049 ≥ 100 MPa | > 100 MPa |
| ISO 10477 ≥ 50 MPa | - | |
| Water Absorption | ISO 4049 ≤ 40 µg/mm³ |
§ 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.