Dentin Conditioning GEL
22% POLYACRYLIC ACID KIT: 4 x 1.2 mL syringes + 8 pre-bent needles
10manufacturers in China registered for this device type
1catalogue number
29510(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 | Pulpdent Corporation, United States |
|---|---|
| FDA product code | EBF |
| Device type | Material, Tooth Shade, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3690 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K901051 |
| Record published | 2016-07-21 |
| Record revised | 2025-10-09 (version 4) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DEN | 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 |
|---|---|
| K210045 | 2021-09-22 |
| K153249 | 2016-04-01 |
| K113617 | 2012-03-02 |
| K090391 | 2009-05-11 |
| K071278 | 2007-06-29 |
| K031877 | 2003-08-01 |
| K022492 | 2002-10-11 |
| K020432 | 2002-04-17 |
| K971594 | 1997-09-12 |
| K963652 | 1996-10-11 |
| K945173 | 1994-12-15 |
| K945057 | 1994-12-14 |
| K945056 | 1994-12-14 |
| K945058 | 1994-12-14 |
| K945113 | 1994-12-14 |
| K945018 | 1994-12-14 |
| K932793 | 1993-09-13 |
| K932792 | 1993-09-09 |
| K926074 | 1993-03-16 |
| K922755 | 1992-08-20 |
| K920483 | 1992-04-29 |
| K920485 | 1992-04-29 |
| K920484 | 1992-04-28 |
| K920482 | 1992-04-28 |
| K901051 | 1990-04-30 |
| K896653 | 1990-02-14 |
| K896658 | 1990-02-14 |
| K896654 | 1990-02-14 |
| K896662 | 1990-02-14 |
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.