Tetric EvoCeram

Tetric EvoCeram (A1, A2, A3, A3.5, B1, Bleach L, T, A2 Dentin), Cavifil Injector Refill Redesign

Registry build 21.09.26
10manufacturers in China registered for this device type
163catalogue 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 Tetric EvoCeram
Listed by Ivoclar Vivadent Aktiengesellschaft
FDA product code EBF
Device type Material, Tooth Shade, Resin
Device class Class 2
Regulation 21 CFR 872.3690
Record published 2016-12-12
Record revised 2022-02-07 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Packaging Pack of 10
Distribution end date 2024-03-11

Catalogue Numbers

Catalogue numbers for Tetric EvoCeram
Catalogue number Size Per pack Status
590304WW 3 In distribution
637354WW 20 In distribution
590325WW In distribution
590332WW 20 In distribution
637354US 20 In distribution
590308WW 3 In distribution
637356WW 20 In distribution
590343WW 20 In distribution
590302WW 3 In distribution
637547WW In distribution
590334WW 20 In distribution
590333WW 20 In distribution
590320WW In distribution
590316WW In distribution
642043WW 10 In distribution
590316WW In distribution
590334WW 20 In distribution
637355WW 20 In distribution
642041WW 150 In distribution
590332US 20 In distribution
590314US In distribution
590321WW In distribution
590297WW 3 In distribution
590340WW 20 In distribution
590345US 20 In distribution
590348WW 20 In distribution
590326US In distribution
637356WW 20 In distribution
590314WW In distribution
590317WW In distribution
590334US 20 In distribution
590321WW In distribution
590347WW 20 In distribution
590312WW In distribution
590323WW In distribution
590326WW In distribution
590320WW In distribution
590315US In distribution
590296WW 3 In distribution
762519WW In distribution
590303WW 3 In distribution
590339WW 20 In distribution
590335US 20 In distribution
590331US 20 In distribution
590313US In distribution
590297WW 3 In distribution
590345WW 20 In distribution
590295WW 3 In distribution
590339WW 20 In distribution
590324WW In distribution
590345US 20 In distribution
590293WW 3 In distribution
590324WW In distribution
590319WW In distribution
590331WW 20 In distribution
590346WW 20 In distribution
637356US 20 In distribution
637548WW In distribution
637549WW In distribution
590344WW 20 In distribution
590307WW 3 In distribution
590341WW 20 In distribution
590315WW In distribution
590308WW 3 In distribution
637355WW In distribution
590332WW 20 In distribution
590319WW In distribution
637354US 20 In distribution
590327WW In distribution
637548WW In distribution
590318WW In distribution
590330WW In distribution
590313WW In distribution
590335US 20 In distribution
590345WW 20 In distribution
590338WW 20 In distribution
590336WW 20 In distribution
590327WW In distribution
590326WW In distribution
590336WW 20 In distribution
590333US 20 In distribution
590315WW In distribution
590340WW 20 In distribution
590301WW 3 In distribution
637356US 20 In distribution
590333WW 20 In distribution
590330WW In distribution
590349WW 20 In distribution
590294WW 3 In distribution
590331US 20 In distribution
590322WW In distribution
590312WW In distribution
590325WW In distribution
590317WW In distribution
590315US In distribution
762518WW 20 In distribution
590312US In distribution
590332US 20 In distribution
590326US In distribution
590333US 20 In distribution
590313WW In distribution
637549WW In distribution
590335WW 20 In distribution
590322WW In distribution
590295WW 3 In distribution
642040WW 150 In distribution
590293WW 3 In distribution
590346WW 20 In distribution
590343WW 20 In distribution
590302WW 3 In distribution
590342WW 20 In distribution
590337WW 20 In distribution
637354WW 20 In distribution
590328WW In distribution
590342WW 20 In distribution
590304WW 3 In distribution
590313US In distribution
590329WW In distribution
590298WW 3 In distribution
637736WW 3 In distribution
590337WW 20 In distribution
590349WW 20 In distribution
590314WW In distribution
637547WW In distribution
590312US In distribution
590344WW 20 In distribution
590338WW 20 In distribution
590298WW 3 In distribution
590314US In distribution
590328WW In distribution
590318WW In distribution
590335WW 20 In distribution
590348WW 20 In distribution
642042WW 10 In distribution
590329WW In distribution
590294WW 3 In distribution
590347WW 20 In distribution
590303WW 3 In distribution
590334US 20 In distribution
590341WW 20 In distribution
590296WW 3 In distribution
590331WW 20 In distribution
637736WW 3 In distribution
590307WW 3 In distribution
590323WW In distribution
590300WW 3 Withdrawn
590311WW 3 Withdrawn
641201WW 3 Withdrawn
637735WW 3 Withdrawn
590310WW 3 Withdrawn
590291WW Withdrawn
590309WW 3 Withdrawn
637734WW 3 Withdrawn
590299WW 3 Withdrawn
638378WW Withdrawn
590290WW Withdrawn
628838AN Withdrawn
638503 3 Withdrawn
638381WW Withdrawn
594774WW 3 Withdrawn
590305WW 3 Withdrawn
590301WW 3 Withdrawn
590306WW 3 Withdrawn

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
IPS Empress Direct Ivoclar Vivadent Aktiengesellschaft 147

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