Everx Flow
everX Flow is a light cured, short fiber reinforced composite used as a dentin replacement in restorations of front and back teeth. Its indications include direct composite restorations,…
everX Flow is a light cured, short fiber reinforced composite used as a dentin replacement in restorations of front and back teeth. Its indications include direct composite restorations, large posterior cavities, deep cavities, root canal treated teeth and core buildup.
The material is supplied in a syringe and is available in Bulk and Dentin shades. Its reinforcing role applies to cavities with missing cusps, cavities after amalgam removal and situations where an inlay or onlay might otherwise be considered.
Listed Item
everX Flow, Dentin Shade
Supply and Storage
The packaged syringe contains 3.7 grams in 2 mL and is supplied with dispensing tips and a light protective cap. Recommended storage is in a cool, dark place at 4 to 25 degrees Celsius, away from high temperatures and direct sunlight.
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 | GC America Inc., United States |
|---|---|
| FDA product code | EBF |
| Device type | Material, Tooth Shade, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3690 |
| Establishment | Contract manufacturer, Remanufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K192260 |
| Record published | 2021-08-20 |
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 4 to 25 °C; Storage environment temperature 39 to 77 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 012899 | In distribution | |
| 012899 | In distribution | |
| 012898 | 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 |
|---|---|
| K261246 | 2026-06-18 |
| K251946 | 2025-08-29 |
| K192260 | 2019-11-22 |
| K173500 | 2018-03-08 |
| K153325 | 2016-07-12 |
| K153127 | 2016-05-20 |
| K151541 | 2015-10-09 |
| K133182 | 2014-04-09 |
| K133824 | 2014-03-14 |
| K123631 | 2013-07-23 |
| K091388 | 2009-07-22 |
| K090747 | 2009-06-10 |
| K082434 | 2008-11-14 |
| K082171 | 2008-10-30 |
| K080478 | 2008-06-05 |
| K070190 | 2007-03-12 |
| K042348 | 2004-11-18 |
| K033808 | 2004-02-02 |
| K023814 | 2003-01-30 |
| K020342 | 2002-03-28 |
| K001518 | 2000-07-05 |
| K993973 | 2000-01-11 |
| K942993 | 1995-02-07 |
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.