VisCalor
The FDA filing names VisCalor as its trade/device name and gives the regulation name as Tooth Shade Resin Material. Its indications include Class I to V restorations, class I and II cavity…
The FDA filing names VisCalor as its trade/device name and gives the regulation name as Tooth Shade Resin Material.
Its indications include Class I to V restorations, class I and II cavity bases, repair of veneers, fissure sealing and core build-up.
Listed Item
VisCalor is a light-curing, radiopaque, nano-hybrid restorative material. Set contains VisCalor Dispenser.
Listed Uses
The same list includes reconstruction of traumatically damaged anteriors, repair of small enamel defects, temporary C&B materials, restoration of deciduous teeth and composite inlays.
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 | Voco Gmbh, Germany |
|---|---|
| FDA product code | EBF |
| Device type | Material, Tooth Shade, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3690 |
| Establishment | Specification developer, Repacker / relabeller, Private-label distributor, Manufacturer, Exporter |
| 510(k) | K201307 |
| Record published | 2020-07-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 4 to 23 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 6123 | 16 | In distribution | |
| 6113 | 16 | In distribution | |
| 6107 | 80 | In distribution | |
| 6109 | 80 | In distribution | |
| 6122 | 16 | In distribution | |
| 6114 | 16 | In distribution | |
| 6116 | 16 | In distribution | |
| 6118 | 16 | In distribution | |
| 6115 | 16 | In distribution | |
| 6120 | 16 | In distribution | |
| 6110 | In distribution | ||
| 6117 | 16 | In distribution | |
| 6121 | 16 | In distribution | |
| 6106 | 80 | In distribution | |
| 6119 | 16 | 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 |
|---|---|
| K261357 | 2026-04-27 |
| K251239 | 2025-05-21 |
| K230877 | 2023-07-13 |
| K201307 | 2020-07-08 |
| K200294 | 2020-03-27 |
| K190453 | 2019-04-11 |
| K181312 | 2018-08-22 |
| K171815 | 2017-11-15 |
| K171200 | 2017-08-10 |
| K170896 | 2017-06-29 |
| K153493 | 2016-07-29 |
| K153177 | 2016-06-30 |
| K151956 | 2015-10-20 |
| K150784 | 2015-07-02 |
| K123773 | 2012-12-21 |
| K113444 | 2011-12-21 |
| K113563 | 2011-12-21 |
| K112447 | 2011-11-08 |
| K112374 | 2011-10-20 |
| K110589 | 2011-05-27 |
| K103580 | 2011-01-21 |
| K102354 | 2010-11-08 |
| K102351 | 2010-11-02 |
| K102450 | 2010-10-08 |
| K101213 | 2010-08-19 |
| K090843 | 2009-06-17 |
| K071386 | 2007-06-05 |
| K063604 | 2007-01-22 |
| K062345 | 2006-12-15 |
| K062343 | 2006-11-02 |
| K060893 | 2006-05-25 |
| K053391 | 2006-02-15 |
| K051867 | 2005-07-27 |
| K051868 | 2005-07-27 |
| K033117 | 2003-11-25 |
| K030914 | 2003-05-30 |
| K030915 | 2003-05-30 |
| K022797 | 2002-10-10 |
| K014111 | 2002-03-06 |
| K011756 | 2001-07-18 |
| K994304 | 2000-02-07 |
| K994268 | 2000-02-03 |
| K994056 | 2000-01-12 |
| K926418 | 1993-03-31 |
| K920365 | 1992-03-19 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-07-09 | Class II | Process control | The metal cannula are potentially too loose and may become loose when applying the filing material. | 5 units | 2023-04-20 |
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.