Grandio SO
Grandio SO is a light-curing dental filling composite based on methacrylate resin with a high proportion of inorganic filler. It can be shaped and contoured in the tooth before curing and…
Grandio SO is a light-curing dental filling composite based on methacrylate resin with a high proportion of inorganic filler. It can be shaped and contoured in the tooth before curing and finishing.
The material uses nanohybrid technology, combining inorganic fillers of different particle sizes. It is supplied in tooth-like shades and is used for restorations across cavity Classes I to V.
Listed Item
Universal nano-hybrid restorative material. The kit contains different shades of Grandio SO and a shade guide.
Restorative Applications
The range also covers core build-ups under crowns, composite inlays, repair of veneers and restoration of primary teeth. Other uses include rebuilding damaged anterior teeth and correcting their shape or shade. The composite is placed and light cured using the workflow for condensable dental restorative materials.
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) | K102351 |
| Record published | 2016-08-31 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 4 to 23 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 2624 | In distribution | ||
| 2652 | 16 | In distribution | |
| 2669 | 16 | In distribution | |
| 2619 | In distribution | ||
| 2611 | In distribution | ||
| 2656 | 16 | In distribution | |
| 2627 | In distribution | ||
| 2615 | In distribution | ||
| 2664 | 16 | In distribution | |
| 2633 | In distribution | ||
| 2635 | In distribution | ||
| 2650 | 16 | In distribution | |
| 2653 | 16 | In distribution | |
| 2673 | 16 | In distribution | |
| 2654 | 16 | In distribution | |
| 2648 | 2 | In distribution | |
| 2629 | In distribution | ||
| 2667 | 16 | In distribution | |
| 2630 | In distribution | ||
| 2613 | In distribution | ||
| 2631 | In distribution | ||
| 2660 | 16 | In distribution | |
| 2620 | In distribution | ||
| 2659 | 16 | In distribution | |
| 2671 | 16 | In distribution | |
| 2661 | 16 | In distribution | |
| 2670 | 16 | In distribution | |
| 2614 | In distribution | ||
| 2646 | In distribution | ||
| 2651 | 16 | In distribution | |
| 2610 | In distribution | ||
| 2616 | In distribution | ||
| 2600 | In distribution | ||
| 2655 | 16 | In distribution | |
| 2640 | 80 | In distribution | |
| 2675 | 16 | In distribution | |
| 2612 | In distribution | ||
| 2621 | 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.