Hexa
Hexa Etch Gel 37% , 50ml , 4/1.2ml Syringes Blue JUMBO, HE-1050 + 50 pre bent tips
10manufacturers in China registered for this device type
29catalogue numbers in this listing
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 | Hexa Dental, United States |
|---|---|
| FDA product code | EBF |
| Device type | Material, Tooth Shade, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3690 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K982191 |
| Record published | 2023-03-28 |
| Record revised | 2024-01-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Box of 64 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| CS-2003 | In distribution | ||
| CS-2008 | In distribution | ||
| CS-2001 | In distribution | ||
| CU-2009 | 20 | In distribution | |
| CU-2002 | 20 | In distribution | |
| CS-2006 | In distribution | ||
| CS-2002 | In distribution | ||
| CU-2004 | 20 | In distribution | |
| CU-2001 | 20 | In distribution | |
| HFL-1002 | In distribution | ||
| CU-2008 | 20 | In distribution | |
| HF-3003 | In distribution | ||
| HE-1050 | In distribution | ||
| CU-2011 | 20 | In distribution | |
| CS-2004 | In distribution | ||
| HF-3001 | In distribution | ||
| HFL-3001 | In distribution | ||
| HE-1050 | In distribution | ||
| HF-3006 | In distribution | ||
| HF-3002 | In distribution | ||
| CU-2003 | 20 | In distribution | |
| HF-3004 | In distribution | ||
| HFL-2001 | In distribution | ||
| HFL-1003 | In distribution | ||
| CS-2009 | In distribution | ||
| HD-1005 | In distribution | ||
| CU-2006 | 20 | In distribution | |
| HFL-1001 | In distribution | ||
| CS-2007 | 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
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.