Class V Procedure KIT
CLASS V PROCEDURE KIT. Contains DI's: E23505020, E23505030, E235Y24510, E2351782S0
10manufacturers in China registered for this device type
1catalogue number
27510(k) clearances naming this product code
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 | Shofu Dental Corp., United States |
|---|---|
| FDA product code | EBF |
| Device type | Material, Tooth Shade, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3690 |
| Establishment | Repacker / relabeller |
| 510(k) | K172530 |
| Record published | 2021-02-18 |
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 1 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CVPK | 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 |
|---|---|
| K251578 | 2025-05-27 |
| K200470 | 2021-02-05 |
| K182869 | 2019-01-09 |
| K180649 | 2018-06-11 |
| K172530 | 2017-12-06 |
| K162261 | 2017-01-11 |
| K160596 | 2016-07-27 |
| K160086 | 2016-07-21 |
| K151700 | 2016-03-02 |
| K151699 | 2015-12-10 |
| K132748 | 2013-12-04 |
| K132141 | 2013-10-03 |
| K130841 | 2013-09-11 |
| K131504 | 2013-07-16 |
| K101621 | 2010-08-23 |
| K101603 | 2010-08-23 |
| K080068 | 2008-02-28 |
| K071742 | 2007-08-15 |
| K051818 | 2005-08-03 |
| K050401 | 2005-04-28 |
| K010914 | 2001-04-20 |
| K972292 | 1997-10-29 |
| K920892 | 1992-09-01 |
| K920893 | 1992-09-01 |
| K913947 | 1991-10-09 |
| K871898 | 1987-07-21 |
| K871899 | 1987-07-21 |
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.