Ena HRI ®
Ena HRi Complete Kit 15 Colours: EFFUD3, EH2OA, EH2OBN, EHRIM, EHRIW, EHRIWS, EHRUD0, EHRUD0,5, EHRUD1, EHRUD2, EHRUD3, EHRUD3,5, EHRUD4, EHRUD5, EHRUD6, EHRUE1, EHRUE2, EHRUE3 Light Curing…
Ena HRi Complete Kit 15 Colours: EFFUD3, EH2OA, EH2OBN, EHRIM, EHRIW, EHRIWS, EHRUD0, EHRUD0,5, EHRUD1, EHRUD2, EHRUD3, EHRUD3,5, EHRUD4, EHRUD5, EHRUD6, EHRUE1, EHRUE2, EHRUE3 Light Curing Composite
10manufacturers in China registered for this device type
221catalogue 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 | Micerium SPA |
|---|---|
| FDA product code | EBF |
| Device type | Material, Tooth Shade, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3690 |
| 510(k) | K062906 |
| Record published | 2016-12-05 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 3 to 25 °C |
| Sizes | Weight 1 to 81 g |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| ERIW | Weight 2.5 g | In distribution | |
| EHRTBD3 | Weight 3.6 g | 12 | In distribution |
| EHRFUD0 | Weight 2 g | In distribution | |
| ERBF2 | Weight 2.5 g | In distribution | |
| EFFUD3,5 | Weight 1 g | In distribution | |
| ERUD0,5 | Weight 2.5 g | In distribution | |
| EHRIW | Weight 5 g | In distribution | |
| ERBD1 | Weight 2.5 g | In distribution | |
| EHR15 | Weight 81 g | In distribution | |
| EHRBD0 | Weight 5 g | In distribution | |
| EHRBD4 | Weight 5 g | In distribution | |
| EHRTBD6 | Weight 3.6 g | 12 | In distribution |
| EFFUD3,5 | Weight 1 g | In distribution | |
| EHRUD6 | Weight 5 g | In distribution | |
| EHRBD0,5 | Weight 5 g | In distribution | |
| EHRBD1 | Weight 5 g | In distribution | |
| EFFUD5 | Weight 1 g | In distribution | |
| EHRBD0,5 | Weight 5 g | In distribution | |
| EHRUD5 | Weight 5 g | In distribution | |
| EHR3FB | Weight 7.5 g | In distribution | |
| EHRBD2 | Weight 5 g | In distribution | |
| EHRUD2 | Weight 5 g | In distribution | |
| EHF7N | Weight 2 g | In distribution | |
| EHRFUD0 | Weight 2 g | In distribution | |
| ER3E | Weight 7.5 g | In distribution | |
| ERUD5 | Weight 2.5 g | In distribution | |
| EHRIWS | Weight 5 g | In distribution | |
| EHRTUE3 | Weight 3.6 g | 12 | In distribution |
| EHRUD1 | Weight 5 g | In distribution | |
| EHRFUD4 | Weight 2 g | In distribution | |
| EHRTBD3,5 | Weight 3.6 g | 12 | In distribution |
| ERUD2 | Weight 2.5 g | In distribution | |
| EHF6N | Weight 2 g | In distribution | |
| ERBD3 | Weight 2.5 g | In distribution | |
| EHRTUD0 | Weight 3.6 g | 12 | In distribution |
| EHRFUD3 | Weight 2 g | In distribution | |
| EH2OBN | Weight 2.5 g | In distribution | |
| EHRBD2 | Weight 5 g | In distribution | |
| EFFUD1 | Weight 1 g | In distribution | |
| EHTSF | Weight 7.5 g | In distribution | |
| ERBD4 | Weight 2.5 g | In distribution | |
| EHRIWS | Weight 5 g | In distribution | |
| EHRFUD2 | Weight 2 g | In distribution | |
| EHRTBD5 | Weight 3.6 g | 12 | In distribution |
| EHTS2 | Weight 7.5 g | In distribution | |
| EHRIW | Weight 5 g | In distribution | |
| EH2OBN | Weight 2.5 g | In distribution | |
| EHRBD3 | Weight 5 g | In distribution | |
| EHRBF1 | Weight 5 g | In distribution | |
| EHRBF2 | Weight 5 g | In distribution | |
| ERUE3 | Weight 2.5 g | In distribution | |
| EFFUD3 | Weight 1 g | In distribution | |
| EHRTBD0,5 | Weight 3.6 g | 12 | In distribution |
| EHRBD6 | Weight 5 g | In distribution | |
| ERIW | Weight 2.5 g | In distribution | |
| EHF7N | Weight 2 g | In distribution | |
| EHF1N | Weight 2 g | In distribution | |
| EHREF3 | Weight 5 g | In distribution | |
| ERBD2 | Weight 2.5 g | In distribution | |
| EHR4F | Weight 8 g | In distribution | |
| EHREF2 | Weight 5 g | In distribution | |
| EHTSF1 | Weight 7.5 g | In distribution | |
| EHR6T | Weight 10.8 g | 36 | In distribution |
| EHRUD0 | Weight 5 g | In distribution | |
| EHRBD0 | Weight 5 g | In distribution | |
| EHREF1 | Weight 5 g | In distribution | |
| EFFUD2 | Weight 1 g | In distribution | |
| EHR6FC | Weight 15 g | In distribution | |
| EHTSF | Weight 7.5 g | In distribution | |
| ERUD1 | Weight 2.5 g | In distribution | |
| EHREF2 | Weight 5 g | In distribution | |
| EHR6B | Weight 15 g | In distribution | |
| EREF2 | Weight 2.5 g | In distribution | |
| EHRTIW | Weight 3.6 g | 12 | In distribution |
| ERUE2 | Weight 2.5 g | In distribution | |
| ERIWS | Weight 2.5 g | In distribution | |
| EHRFUD5 | Weight 2 g | In distribution | |
| EHRBD4 | Weight 5 g | In distribution | |
| ERUE1 | Weight 2.5 g | In distribution | |
| EHRUD2 | Weight 5 g | In distribution | |
| EHRBF3 | Weight 5 g | In distribution | |
| EHRTBD1 | Weight 3.6 g | 12 | In distribution |
| EHRUD1 | Weight 5 g | In distribution | |
| EHRFUD3,5 | Weight 2 g | In distribution | |
| EHR15 | Weight 81 g | In distribution | |
| EREF3 | Weight 2.5 g | In distribution | |
| EREF1 | Weight 2.5 g | In distribution | |
| ERUE3 | Weight 2.5 g | In distribution | |
| ER3FB | Weight 7.5 g | In distribution | |
| EHRTBF3 | Weight 3.6 g | 12 | In distribution |
| ER3E | Weight 7.5 g | In distribution | |
| EHRBD1 | Weight 5 g | In distribution | |
| EHF3N | Weight 2 g | In distribution | |
| EHR3FC | Weight 7.5 g | In distribution | |
| EHRUD3,5 | Weight 5 g | In distribution | |
| EHRTUD3,5 | Weight 3.6 g | 12 | In distribution |
| EHRTBF2 | Weight 3.6 g | 12 | In distribution |
| EHRTUE1 | Weight 3.6 g | 12 | In distribution |
| EHR6B | Weight 15 g | In distribution | |
| EHREF1 | Weight 5 g | In distribution | |
| EHR3FC | Weight 7.5 g | In distribution | |
| ERUD3,5 | Weight 2.5 g | In distribution | |
| EHF4N | Weight 2 g | In distribution | |
| EREF1 | Weight 2.5 g | In distribution | |
| EHRFUD5 | Weight 2 g | In distribution | |
| EHRTUD2 | Weight 3.6 g | 12 | In distribution |
| EREF2 | Weight 2.5 g | In distribution | |
| EHRFUD6 | Weight 2 g | In distribution | |
| EHTSF1 | Weight 7.5 g | In distribution | |
| EHRBF2-F | Weight 6 g | In distribution | |
| EHRFUD3 | Weight 2 g | In distribution | |
| EHREF3 | Weight 5 g | In distribution | |
| ERBF2 | Weight 2.5 g | In distribution | |
| EHRTUD6 | Weight 3.6 g | 12 | In distribution |
| ERUD0,5 | Weight 2.5 g | In distribution | |
| EHRUD3 | Weight 5 g | In distribution | |
| EHRBF2 | Weight 5 g | In distribution | |
| ERIWS | Weight 2.5 g | In distribution | |
| ERUE2 | Weight 2.5 g | In distribution | |
| EHRFUD4 | Weight 2 g | In distribution | |
| EFFUD6 | Weight 1 g | In distribution | |
| EHRTUD4 | Weight 3.6 g | 12 | In distribution |
| EHRTIM | Weight 3.6 g | 12 | In distribution |
| EHRUE2 | Weight 5 g | In distribution | |
| EHRFUD1 | Weight 2 g | In distribution | |
| ER3FC | Weight 7.5 g | In distribution | |
| EHOA | Weight 5 g | In distribution | |
| EHRUE1 | Weight 5 g | In distribution | |
| EHRTUE2 | Weight 3.6 g | 12 | In distribution |
| EHRUD5 | Weight 5 g | In distribution | |
| ERUD2 | Weight 2.5 g | In distribution | |
| ERUD4 | Weight 2.5 g | In distribution | |
| ERUD3 | Weight 2.5 g | In distribution | |
| EHR4FC | Weight 10 g | In distribution | |
| EHRFUD3,5 | Weight 2 g | In distribution | |
| EFFUD6 | Weight 1 g | In distribution | |
| EHF5N | Weight 2 g | In distribution | |
| EHRTUD5 | Weight 3.6 g | 12 | In distribution |
| EHRUD4 | Weight 5 g | In distribution | |
| EHRFUD6 | Weight 2 g | In distribution | |
| EHRTBD4 | Weight 3.6 g | 12 | In distribution |
| ERUD0 | Weight 2.5 g | In distribution | |
| EHOBN | Weight 4.5 g | In distribution | |
| EFFUD2 | Weight 1 g | In distribution | |
| EHF6N | Weight 2 g | In distribution | |
| EHRUE1 | Weight 5 g | In distribution | |
| EHRUD6 | Weight 5 g | In distribution | |
| EHRFUD1 | Weight 2 g | In distribution | |
| EHR4F | Weight 8 g | In distribution | |
| EHRUE3 | Weight 5 g | In distribution | |
| EHRTEF3 | Weight 3.6 g | 12 | In distribution |
| EFFUD4 | Weight 1 g | In distribution | |
| ETST | Weight 2 g | In distribution | |
| EHFS | Weight 2 g | In distribution | |
| ER3FB | Weight 7.5 g | In distribution | |
| EFFUD5 | Weight 1 g | In distribution | |
| EHRTUD1 | Weight 3.6 g | 12 | In distribution |
| EHRBF3 | Weight 5 g | In distribution | |
| EHRIM | Weight 5 g | In distribution | |
| EHRBD6 | Weight 5 g | In distribution | |
| EHRUD0,5 | Weight 5 g | In distribution | |
| ERUD0 | Weight 2.5 g | In distribution | |
| ER3FC | Weight 7.5 g | In distribution | |
| EHRTBF1 | Weight 3.6 g | 12 | In distribution |
| ERUD3 | Weight 2.5 g | In distribution | |
| EHF3N | Weight 2 g | In distribution | |
| ERUD4 | Weight 2.5 g | In distribution | |
| EHRUD0 | Weight 5 g | In distribution | |
| ERUD3,5 | Weight 2.5 g | In distribution | |
| EHR5UB | Weight 7.5 g | In distribution | |
| EHTOA | Weight 3.6 g | 12 | In distribution |
| ERUE1 | Weight 2.5 g | In distribution | |
| EHRBD5 | Weight 5 g | In distribution | |
| ERBF1 | Weight 2.5 g | In distribution | |
| EHRUE2 | Weight 5 g | In distribution | |
| EHRFUD0,5 | Weight 2 g | In distribution | |
| EHRUD0,5 | Weight 5 g | In distribution | |
| EHRBD5 | Weight 5 g | In distribution | |
| EHF1N | Weight 2 g | In distribution | |
| ERUD5 | Weight 2.5 g | In distribution | |
| EHRBD3 | Weight 5 g | In distribution | |
| EHRTIWS | Weight 3.6 g | 12 | In distribution |
| EFFUD1 | Weight 1 g | In distribution | |
| EHRTEF2 | Weight 3.6 g | 12 | In distribution |
| ERBF3 | Weight 2.5 g | In distribution | |
| ERUD1 | Weight 2.5 g | In distribution | |
| EREF3 | Weight 2.5 g | In distribution | |
| EHF4N | Weight 2 g | In distribution | |
| EHRBD3,5 | Weight 5 g | In distribution | |
| EHRUD4 | Weight 5 g | In distribution | |
| ERBF3 | Weight 2.5 g | In distribution | |
| EH2OA | Weight 2.5 g | In distribution | |
| EHR4FC | Weight 10 g | In distribution | |
| EHRTBD2 | Weight 3.6 g | 12 | In distribution |
| EHRUE3 | Weight 5 g | In distribution | |
| EHRFUD2 | Weight 2 g | In distribution | |
| EHRIM | Weight 5 g | In distribution | |
| EHOA | Weight 5 g | In distribution | |
| EHTOBN | Weight 3.6 g | 12 | In distribution |
| EH2OA | Weight 2.5 g | In distribution | |
| EHRTBD0 | Weight 3.6 g | 12 | In distribution |
| EFFUD4 | Weight 1 g | In distribution | |
| EHRUD3,5 | Weight 5 g | In distribution | |
| EHRTUD0,5 | Weight 3.6 g | 12 | In distribution |
| EHFS | Weight 2 g | In distribution | |
| ETST | Weight 2 g | In distribution | |
| EHRFUD0,5 | Weight 2 g | In distribution | |
| EHF5N | Weight 2 g | In distribution | |
| EHTS2 | Weight 7.5 g | In distribution | |
| EHOBN | Weight 4.5 g | In distribution | |
| EHRTUD3 | Weight 3.6 g | 12 | In distribution |
| EHRTEF1 | Weight 3.6 g | 12 | In distribution |
| EHF8N | Weight 2 g | In distribution | |
| EFFUD3 | Weight 1 g | In distribution | |
| EHR6FC | Weight 15 g | In distribution | |
| EHRBD3,5 | Weight 5 g | In distribution | |
| EHRUD3 | Weight 5 g | In distribution | |
| EHRBF1 | Weight 5 g | In distribution | |
| ERBF1 | Weight 2.5 g | In distribution | |
| EHF8N | Weight 2 g | In distribution | |
| EHR5UB | Weight 7.5 g | 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 |
| 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 |
| IPS Empress Direct | Ivoclar Vivadent Aktiengesellschaft | 147 |
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.