Grandio
Excellent physical properties for long-lasting restorations. Significantly lower polymerisation shrinkae than conventional composites. High filler content of 87 % w/w. Extremely high…
Excellent physical properties for long-lasting restorations. Significantly lower polymerisation shrinkae than conventional composites. High filler content of 87 % w/w. Extremely high abrasion resistance. High transverse strength. Smooth consistency for convenient handling. Shade guide made from original material.
10manufacturers in China registered for this device type
37catalogue numbers in this listing
45510(k) clearances naming this product code
1recall
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) | K051867 |
| 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 |
|---|---|---|---|
| 1849 | 20 | In distribution | |
| 1808 | In distribution | ||
| 1824 | In distribution | ||
| 1812 | In distribution | ||
| 1823 | In distribution | ||
| 1855 | 20 | In distribution | |
| 1820 | In distribution | ||
| 1811 | In distribution | ||
| 1814 | In distribution | ||
| 1848 | 20 | In distribution | |
| 1852 | 20 | In distribution | |
| 1813 | In distribution | ||
| 1843 | 20 | In distribution | |
| 1818 | In distribution | ||
| 1815 | In distribution | ||
| 1805 | 10 | In distribution | |
| 1817 | In distribution | ||
| 1853 | 20 | In distribution | |
| 1845 | 20 | In distribution | |
| 1851 | 20 | In distribution | |
| 1841 | 20 | In distribution | |
| 1840 | 20 | In distribution | |
| 1810 | In distribution | ||
| 1854 | 20 | In distribution | |
| 1819 | In distribution | ||
| 1800 | In distribution | ||
| 1844 | 20 | In distribution | |
| 1822 | In distribution | ||
| 1850 | 20 | In distribution | |
| 1825 | In distribution | ||
| 1846 | 20 | In distribution | |
| 1838 | In distribution | ||
| 1842 | 20 | In distribution | |
| 1830 | 50 | In distribution | |
| 1821 | In distribution | ||
| 1847 | 20 | In distribution | |
| 1816 | 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 |
|---|---|---|---|---|---|---|
| Henry Schein, Inc. | 510(k) number | 2026-07-09 | Class II | Process control | Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device. | 853 units |
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.