VarseoSmile Crown Plus
VarseoSmile Crown plus is a light cured, methacrylate based resin for three dimensional printing of permanent dental crowns, inlays, onlays and veneers. Dentists and dental technicians use…
VarseoSmile Crown plus is a light cured, methacrylate based resin for three dimensional printing of permanent dental crowns, inlays, onlays and veneers. Dentists and dental technicians use it within a CAD/CAM workflow to produce fixed indirect restorations, including restorations of chewing surfaces.
The viscous material contains methacrylate resins, dental glass filler, photoinitiators and pigments. Compatible printers form the restoration, followed by a separate light postcuring step. Both curing stages take place outside the patient.
Digital Restoration Workflow
Dental CAD software defines the restoration’s shape and contour and generates an STL dataset for fabrication within a validated manufacturing workflow. The resin is available in different tooth shades. The finished restorations are prescription devices intended for permanent, one time placement.
Who Else Makes It
Concentrated in Guangdong (3), Shandong (2), Jilin (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Aidite (Qinhuangdao) Technology Co., Ltd. | Qinhuangdao | Hebei | Repacker / relabeller | 17 |
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Liaoning Upcera Co., Ltd. | Benxi | Liaoning | Contract manufacturer | 10 |
| Shenzhen Upcera Digital Dental Technology Co., Ltd. | Shenzhen | Guangdong | Exporter | 10 |
| Rizhao Huge Biomaterials Company, Ltd. | Rizhao | Shandong | Manufacturer | 7 |
| Hangzhou SHINING3D Dental Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 7 |
| Shenzhen Piocreat 3D Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Shenzhen Upcera Dental Technology Co., Ltd. | Shenzhen | Guangdong | Private-label distributor | 6 |
| Sincera Technology (Changchun) Co., Ltd. | Changchun | Jilin | Manufacturer | 2 |
| Sino-Dentex Co., Ltd. | Changchun | Jilin | Manufacturer | 2 |
Record
| Listed by | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG, Germany |
|---|---|
| FDA product code | EBF |
| Device type | Material, Tooth Shade, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3690 |
| 510(k) | K201668 |
| Record published | 2020-07-17 |
| Record revised | 2021-09-15 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 18 to 28 °C; Storage environment temperature 18 to 28 °C |
| Packaging | Box |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 41111US | In distribution | |
| 41110US | In distribution | |
| 41124US | In distribution | |
| 41123US | In distribution | |
| 41120US | In distribution | |
| 41118US | In distribution | |
| 41117US | In distribution | |
| 41108US | In distribution | |
| 41113US | In distribution | |
| 41122US | In distribution | |
| 41119US | In distribution | |
| 41107US | In distribution | |
| 41114US | In distribution | |
| 41112US | In distribution | |
| 41121US | In distribution | |
| 41109US | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tooth Shade Resin Material | Liaoning Upcera Co., Ltd. | 4,808 |
| Gradia® | GC America Inc. | 548 |
| G-CAM | Graphenano Dental, SL | 320 |
| Vitavm LC | Vita – Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft | 261 |
| G-aenial™ | GC America Inc. | 225 |
| Ena HRI ® | Micerium SPA | 221 |
| Mazic Duro | Vericom Co., Ltd. | 206 |
| Ceramage | Shofu Dental Corp. | 204 |
| Filtek™ | 3M Company | 188 |
| SR Nexco | Ivoclar Vivadent Aktiengesellschaft | 181 |
| Aidite | Aidite (Qinhuangdao) Technology Co., Ltd. | 166 |
| Tetric EvoCeram | Ivoclar Vivadent Aktiengesellschaft | 163 |
Showing 12 of 2,059. All products under Material, Tooth Shade, Resin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233596 | 2023-11-09 |
| K201668 | 2020-06-23 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.