Diafil
DiaFil & DiaFil Capsule is a composite resin for esthetic restorative.
10manufacturers in China registered for this device type
30catalogue numbers in this listing
5510(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 | Diadent Group Intl., Inc., Canada |
|---|---|
| FDA product code | EBF |
| Device type | Material, Tooth Shade, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3690 |
| Establishment | Repacker / relabeller, Private-label distributor, Manufacturer, Exporter |
| Record published | 2020-04-23 |
| Record revised | 2023-10-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 27 °C; Special storage condition: Keep Dry and Keep away from Sunlight |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Capsure Type A3 | In distribution | |
| Refill A1 | In distribution | |
| Refill C1 | In distribution | |
| Intro Kit A1 | In distribution | |
| Intro Kit B1 | In distribution | |
| Capsure Type A3.5 | In distribution | |
| Refill A3O | In distribution | |
| Capsure Type A2 | In distribution | |
| Refill B1 | In distribution | |
| Intro Kit A3.5 | In distribution | |
| Refill C3 | In distribution | |
| Refill A3 | In distribution | |
| Intro Kit C3 | In distribution | |
| Refill A2O | In distribution | |
| Capsure Type A1 | In distribution | |
| Intro Kit B3 | In distribution | |
| Refill A3.5 | In distribution | |
| Intro Kit B2 | In distribution | |
| Intro Kit A2 | In distribution | |
| Capsure Type B2 | In distribution | |
| Refill A2 | In distribution | |
| Refill A4 | In distribution | |
| Refill B2 | In distribution | |
| Intro Kit A3O | In distribution | |
| Intro Kit A2O | In distribution | |
| Intro Kit C2 | In distribution | |
| Refill C2 | In distribution | |
| Refill B3 | In distribution | |
| Intro Kit A4 | In distribution | |
| Intro Kit A3 | 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 |
|---|---|
| K261093 | 2026-06-02 |
| K261071 | 2026-05-19 |
| K210421 | 2021-06-28 |
| K192284 | 2020-03-25 |
| K192510 | 2020-03-20 |
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.