Ecosite Elements
Ecosite Elements is a light-curing, esthetic, radiopaque nanohybrid composite system for the anterior and posterior region. The range of highly viscous composites includes 5 VITA shades…
Ecosite Elements is a light-curing, esthetic, radiopaque nanohybrid composite system for the anterior and posterior region. The range of highly viscous composites includes 5 VITA shades (B1, A2, A3, A3.5 and A4) and 4 enamel shades (Enamel Bleach = EB, Enamel Light = EL, Enamel Medium = EM and Enamel Dark = ED) in different opacities. This, combined with their unique handling and excellent polishing properties contributes to the creation of highly-aesthetic restorations. The shades OA2 (Opak A2) and INC (Incisal) are radiopaque composites with optimum flow composites. The shade OA2 is recommended for the veneering of slightly discolored areas and for creating ultimate tooth opacity. The shade INC is particularly suitable for an esthetic incisal edge design thanks to its high transparency. Both shades are suitable for fissure sealing. The shades W (White) and B (Brown) are flowable composites for the customization of composite restorations. The shade W is used for the reproduction of white spots and as an oqaque covering layer. The shade B is an ideal choice for fissures and the replication of brown spots. Module → Pure Set: 80 Safetips @ 0.25 g (16 x each) in the shades B1, A2, A3, A3.5, A4, 1 bottle @ 5 ml Ecosite-Bond
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 | DMG Chemisch Pharmazeutische Fabrik Gmbh, Germany |
|---|---|
| FDA product code | EBF |
| Device type | Material, Tooth Shade, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3690 |
| Establishment | Manufacturer |
| Record published | 2019-09-06 |
| Record revised | 2021-11-15 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment temperature 36 to 77 °F; Storage environment temperature 2 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 220802 | 4 | In distribution | |
| 220805 | 80 | In distribution | |
| 220801 | 5 | In distribution | |
| 220803 | 4 | In distribution | |
| 220806 | 64 | 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
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.