DiaFil Flow
The subject device is a light-curved complex resin for aesthetic restoration for both anterior and posterior parts, which is used for restoration that requires aesthetics through decay and…
The subject device is a light-curved complex resin for aesthetic restoration for both anterior and posterior parts, which is used for restoration that requires aesthetics through decay and damage in a form of paste with unpolymerized dimethacrylate monomer, inorganic filler, and photoinitiators mixed.
10manufacturers in China registered for this device type
75catalogue 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 | 2020-04-27 |
| 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 |
|---|---|---|
| Intro Kit C3 | In distribution | |
| Intro Kit B1 | In distribution | |
| Economic Package C1 | In distribution | |
| Economic Package B4 | In distribution | |
| Economic Package A2 | In distribution | |
| Refill Package B3 | In distribution | |
| Refill Package C3 | In distribution | |
| Refill Package C1 | In distribution | |
| Intro Kit A4 | In distribution | |
| Economic Package (A2,A2,A3,A3) | In distribution | |
| Intro Kit D4 | In distribution | |
| Intro Kit C4 | In distribution | |
| Economic Package D3 | In distribution | |
| Economic Package A3O | In distribution | |
| Intro Kit C2 | In distribution | |
| Economic Package ASST | In distribution | |
| Economic Package C4 | In distribution | |
| Refill Package A1 | In distribution | |
| Economic Package A4 | In distribution | |
| Intro Kit D2 | In distribution | |
| Economic Package (A1,A1,B2,B2) | In distribution | |
| Economic Package (A2,B3,A20,A30) | In distribution | |
| Intro Kit B3 | In distribution | |
| Economic Package C2 | In distribution | |
| Economic Package (A1,A3,A3.5,B2) | In distribution | |
| Economic Package A3 | In distribution | |
| Refill Package C2 | In distribution | |
| Refill Package C4 | In distribution | |
| Refill Package A3.5 | In distribution | |
| Refill Package B1 | In distribution | |
| Economic Package D2 | In distribution | |
| Economic Package (A2,A3,A3.5,B2) | In distribution | |
| Economic Package C3 | In distribution | |
| Refill Package B2 | In distribution | |
| Refill Package D4 | In distribution | |
| Refill Package D2 | In distribution | |
| Economic Package (A1,A2,A2,A3) | In distribution | |
| Economic Package B3 | In distribution | |
| Refill Pacakge A2O | In distribution | |
| Intro Kit D3 | In distribution | |
| Economic Package (A3.5,A3.5,B2,B2) | In distribution | |
| Economic Package (A3,A3,A3,A3) | In distribution | |
| Economic Package (A2,A3,A3.5,A2O) | In distribution | |
| Economic Package (A1,A2,A3,A3.5) | In distribution | |
| Economic Package A1 | In distribution | |
| Economic Package (A1,A2,A3,B2) | In distribution | |
| Intro Kit A3.5 | In distribution | |
| Intro Kit A30 | In distribution | |
| Intro Kit D1 | In distribution | |
| Economic Package (A2,A3,A3.5,B2) | In distribution | |
| Dia-Fil Flow Refill (0.5g) A2 | In distribution | |
| Intro Kit A20 | In distribution | |
| Refill Package A3O | In distribution | |
| Refill Package A2 | In distribution | |
| Refill Package A4 | In distribution | |
| Economic Package B1 | In distribution | |
| Economic Package D4 | In distribution | |
| Intro Kit B2 | In distribution | |
| Intro Kit A1 | In distribution | |
| Intro Kit C1 | In distribution | |
| Refill Package D1 | In distribution | |
| Intro Kit A3 | In distribution | |
| Refill Package A3 | In distribution | |
| Economic Package (A2,A2,A3.5,A3.5) | In distribution | |
| Intro Kit B4 | In distribution | |
| Economic Package A2O | In distribution | |
| Economic Package (A3.5,A3.5,B1,B2) | In distribution | |
| Economic Package D1 | In distribution | |
| Economic Package A3.5 | In distribution | |
| Refill Package B4 | In distribution | |
| Economic Package (A2,A3,A2O,A3O) | In distribution | |
| Economic Package B2 | In distribution | |
| Intro Kit A2 | In distribution | |
| Economic Package (A2,A3.5,A3.5,A3.5) | In distribution | |
| Refill Package D3 | 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.