TrusFIL Universal Composite Restorative
TrusFIL Universal Composite Restorative is a light-activated resin material for restoring anterior or posterior teeth. It can also be used for core buildup, splinting and specified indirect…
TrusFIL Universal Composite Restorative is a light-activated resin material for restoring anterior or posterior teeth. It can also be used for core buildup, splinting and specified indirect restorations.
Its methacrylate resin matrix includes Bis-GMA, TEGDMA and EBPADMA with inorganic fillers making up approximately 54 percent of the material by volume. The filler particles span approximately 0.01 to 2 micrometers.
Shades and Delivery
The range includes opaque dentin, regular body and enamel shades, all radiopaque. Material is supplied in syringes or single-dose capsules. Capsules are intended for a single patient. Light exposure activates curing after the material has been placed and shaped for the restoration.
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 | Rizhao Huge Biomaterials Company, Ltd., China |
|---|---|
| FDA product code | EBF |
| Device type | Material, Tooth Shade, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3690 |
| Establishment | Manufacturer |
| 510(k) | K202063 |
| Record published | 2025-10-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2023-11-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B2-4g | In distribution | |
| OA2-4g | In distribution | |
| C2 | In distribution | |
| A3-4g | In distribution | |
| A3.5-4g | In distribution | |
| EA2-4g | In distribution | |
| W-VSM-TrusFil Universal Composite Restorative-C2 | In distribution | |
| B3-4g | In distribution | |
| A2-4g | In distribution | |
| A1-4g | Withdrawn | |
| B1-4g | 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 |
|---|---|
| K242572 | 2024-12-20 |
| K233082 | 2023-12-22 |
| K221510 | 2022-10-12 |
| K202063 | 2021-10-06 |
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.