Once-Fil Flow
Once-Fil Flow is a light cured temporary dental filling material for use by licensed dentists and dental professionals. It is used in temporary inlay and onlay treatments and can also seal…
Once-Fil Flow is a light cured temporary dental filling material for use by licensed dentists and dental professionals. It is used in temporary inlay and onlay treatments and can also seal implant screw openings or reline temporary crowns and bridges.
The material is delivered from a syringe through a disposable tip, placed on the prepared surface and hardened with light. After curing, it can be finished and polished with conventional instruments. This listed version is supplied in a yellow shade.
Listed Item
Once-Fil Flow is a light-curing temporary filling material. Yellow shade.
Other Dental Uses
The material can cover the gingival margin, hold a resin matrix during filling placement or block out retentive areas before impressions. It is intended for contact longer than 24 hours but no more than 30 days.
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 | Mediclus Co., Ltd., South Korea |
|---|---|
| FDA product code | EBF |
| Device type | Material, Tooth Shade, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3690 |
| Establishment | Manufacturer |
| 510(k) | K251283 |
| Record published | 2026-05-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 1 to 30 °C |
| Sizes | Total volume 1.2 ml |
| Distribution end date | 2026-05-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 101-1 | Total Volume 1.2 ml | Withdrawn |
| 101-2 | Total Volume 1.2 ml | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252465 | 2025-12-05 |
| K251283 | 2025-06-06 |
| K250823 | 2025-04-14 |
| K242713 | 2025-02-07 |
| K241147 | 2024-09-26 |
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.