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…

Registry build 21.09.26

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

10manufacturers in China registered for this device type
5catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (3), Shandong (2), Jilin (2).

Chinese manufacturers registered for FDA product code EBF
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

Regulatory record for Ecosite Elements
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

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 numbers for Ecosite Elements
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

Other products under the same FDA 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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer