EsCom250
EsCom250 is the polymer-based dental restorative material. It can be light-cured intra orally for anterior and posterior restoration including occlusal surface. Various shades of A1, A2,…
EsCom250 is the polymer-based dental restorative material. It can be light-cured intra orally for anterior and posterior restoration including occlusal surface. Various shades of A1, A2, A3, A3.5, A4, B1, B2, C2, D2, G1, AO2, AO3 and TW for esthetic restoration are provided. All shades of EsCom250 are radio-opaque.
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 | Spident Co., Ltd., South Korea |
|---|---|
| FDA product code | EBF |
| Device type | Material, Tooth Shade, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3690 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2026-04-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EsCom250 B2 | In distribution | |
| EsCom250 D2 | In distribution | |
| EsCom250 B1 | In distribution | |
| EsCom250 Capsule AO2 20ea | In distribution | |
| EsCom250 G1 | In distribution | |
| EsCom250 Capsule C2 20ea | In distribution | |
| EsCom250 Capsule A2 20ea | In distribution | |
| EsCom250 Capsule A4 20ea | In distribution | |
| EsCom250 A3 | In distribution | |
| EsCom250 Capsule B2 20ea | In distribution | |
| EsCom250 A2 | In distribution | |
| EsCom250 Capsule TW 20ea | In distribution | |
| EsCom250 Capsule D2 20ea | In distribution | |
| EsCom250 A4 | In distribution | |
| EsCom250 C2 | In distribution | |
| EsCom250 A3.5 | In distribution | |
| EsCom250 Capsule A3 20ea | In distribution | |
| EsCom250 TW | In distribution | |
| EsCom250 Capsule A1 20ea | In distribution | |
| EsCom250 Capsule A3.5 20ea | In distribution | |
| EsCom250 AO2 | In distribution | |
| EsCom250 Syringe KIT 8syringe | In distribution | |
| EsCom250 Capsule B1 20ea | In distribution | |
| EsCom250 Capsule G1 20ea | In distribution | |
| EsCom250 A1 | In distribution | |
| EsCom250 AO3 | In distribution | |
| EsCom250 Capsule AO3 20ea | 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 |
|---|---|
| K250317 | 2025-05-30 |
| K231523 | 2023-07-24 |
| K120768 | 2012-05-03 |
| K110428 | 2011-02-25 |
| K100413 | 2010-03-03 |
| K092572 | 2009-08-26 |
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.