Grandio SO Heavy Flow
Grandio SO Heavy Flow is a light-curing, methacrylate-based dental filling composite with a shear-thinning consistency. Its nanohybrid structure combines inorganic filler particles of…
Grandio SO Heavy Flow is a light-curing, methacrylate-based dental filling composite with a shear-thinning consistency. Its nanohybrid structure combines inorganic filler particles of different sizes. The material is offered in tooth-like shades and can be placed, cured and polished by dental professionals.
Indications include minimally invasive cavities of all classes, small Class I cavities, extended fissure sealing and Class II to V cavities, including cervical caries and wedge-shaped defects. It may also be used to block undercuts or line and coat cavities.
Listed Item
Flowable universal nano-hybrid restorative material – highly viscous. The kit contains different shades of Grandio SO Heavy Flow, a shade guide and accessories.
Repair and Luting Uses
The material is also indicated for repair of fillings and veneers and for luting translucent prosthetic pieces such as ceramic crowns. The composite is supplied in different tooth-like shades. It can be polished after curing as part of finishing the restoration.
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) | K102354 |
| Record published | 2016-08-31 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| 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 |
|---|---|---|---|
| 2684 | In distribution | ||
| 2696 | In distribution | ||
| 2686 | In distribution | ||
| 2687 | In distribution | ||
| 2704 | 16 | In distribution | |
| 2689 | In distribution | ||
| 2720 | In distribution | ||
| 2694 | In distribution | ||
| 2680 | In distribution | ||
| 2695 | In distribution | ||
| 2699 | In distribution | ||
| 2693 | In distribution | ||
| 2708 | 16 | In distribution | |
| 2685 | In distribution | ||
| 2691 | In distribution | ||
| 2705 | 16 | In distribution | |
| 2692 | In distribution | ||
| 2707 | 16 | In distribution | |
| 2712 | 16 | In distribution | |
| 2688 | In distribution | ||
| 2706 | 16 | In distribution | |
| 2690 | 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 Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Voco Gmbh | 510(k) number | 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.