Tetric Prime
Tetric Prime Refill 1x3g A2, Tetric Prime Refill 1x3g A2 Dentin, Tetric EvoFlow Refill 1x2g A3, Tetric PowerFill Ref. 1x3g IVA, Tetric PowerFlow Refill 1 x 2g IVA, AdheSE Universal 0.5ml…
Tetric Prime Refill 1x3g A2, Tetric Prime Refill 1x3g A2 Dentin, Tetric EvoFlow Refill 1x2g A3, Tetric PowerFill Ref. 1x3g IVA, Tetric PowerFlow Refill 1 x 2g IVA, AdheSE Universal 0.5ml VivaPen (BULK)
10manufacturers in China registered for this device type
80catalogue 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 | Ivoclar Vivadent Aktiengesellschaft |
|---|---|
| FDA product code | EBF |
| Device type | Material, Tooth Shade, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3690 |
| Record published | 2023-02-23 |
| Record revised | 2023-09-01 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 10 |
| Distribution end date | 2025-02-04 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 706610WW | In distribution | ||
| 706597US | 20 | In distribution | |
| 706607WW | In distribution | ||
| 706613WW | In distribution | ||
| 706564US | 20 | In distribution | |
| 706619US | In distribution | ||
| 706594US | 20 | In distribution | |
| 706586US | 20 | In distribution | |
| 706585US | 20 | In distribution | |
| 706613US | In distribution | ||
| 706563US | 20 | In distribution | |
| 706609WW | In distribution | ||
| 706588US | 20 | In distribution | |
| 706585US | 20 | In distribution | |
| 708818WW | 3 | In distribution | |
| 706587US | 20 | In distribution | |
| 706609WW | In distribution | ||
| 706612WW | In distribution | ||
| 706563WW | 20 | In distribution | |
| 706589US | 20 | In distribution | |
| 706612US | In distribution | ||
| 706586US | 20 | In distribution | |
| 706587US | 20 | In distribution | |
| 706619WW | In distribution | ||
| 706591US | 20 | In distribution | |
| 706610WW | In distribution | ||
| 706608WW | In distribution | ||
| 706595US | 20 | In distribution | |
| 706598US | 20 | In distribution | |
| 706615WW | In distribution | ||
| 706611WW | In distribution | ||
| 706621WW | In distribution | ||
| 706622WW | In distribution | ||
| 706565WW | 6 | In distribution | |
| 706612WW | In distribution | ||
| 706615WW | In distribution | ||
| 706613WW | In distribution | ||
| 706611WW | In distribution | ||
| 706589US | 20 | In distribution | |
| 706591US | 20 | In distribution | |
| 706618WW | In distribution | ||
| 706563US | 20 | In distribution | |
| 706608WW | In distribution | ||
| 706607WW | In distribution | ||
| 706594US | 20 | In distribution | |
| 706595US | 20 | In distribution | |
| 706597US | 20 | In distribution | |
| 706622WW | In distribution | ||
| 706564US | 20 | In distribution | |
| 708818WW | 3 | In distribution | |
| 706619WW | In distribution | ||
| 706610US | In distribution | ||
| 706598US | 20 | In distribution | |
| 706588US | 20 | In distribution | |
| 706621WW | In distribution | ||
| 706618WW | In distribution | ||
| 706611US | Withdrawn | ||
| 706618US | Withdrawn | ||
| 706610US | Withdrawn | ||
| 706613US | Withdrawn | ||
| 706608US | Withdrawn | ||
| 706621US | Withdrawn | ||
| 706607US | Withdrawn | ||
| 706622US | Withdrawn | ||
| 706618US | Withdrawn | ||
| 706615US | Withdrawn | ||
| 706565WW | Withdrawn | ||
| 706608US | Withdrawn | ||
| 706622US | Withdrawn | ||
| 706619US | Withdrawn | ||
| 706612US | Withdrawn | ||
| 706607US | Withdrawn | ||
| 706621US | Withdrawn | ||
| 742320WW | Withdrawn | ||
| 706611US | Withdrawn | ||
| 706615US | Withdrawn | ||
| 742319WW | Withdrawn | ||
| 706609US | Withdrawn | ||
| 706609US | Withdrawn | ||
| 745236WW | 4 | Withdrawn |
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.