Variolink Esthetic

Variolink Esthetic DC Light, Neutral, Warm, Variolink Esthetic Try-In-Paste Light, Neutral, Warm, Total Etch, Adhese Universal VivaPen, Monobond Etch & Prime, Liquid Strip, Optra Stick Test…

Registry build 21.09.26

Variolink Esthetic DC Light, Neutral, Warm, Variolink Esthetic Try-In-Paste Light, Neutral, Warm, Total Etch, Adhese Universal VivaPen, Monobond Etch & Prime, Liquid Strip, Optra Stick Test Pack, Cannulas Total Etch / Liquid Strip, VivaPen Brush Cannulas, VivaPen Protective Sleeves, Vivadent Applicators, Mixing Tips, Application Tips Variolink, Various accessories

10manufacturers in China registered for this device type
61catalogue 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 Variolink Esthetic
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 2016-11-11
Record revised 2025-05-19 (version 4)

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 2025-05-16

Catalogue Numbers

Catalogue numbers for Variolink Esthetic
Catalogue number Size Per pack Status
666127WW In distribution
666126WW In distribution
763424WW In distribution
666120WW In distribution
666128WW In distribution
666118WW In distribution
763425WW In distribution
666122WW In distribution
763446WW In distribution
762061WW In distribution
666123WW In distribution
666129WW In distribution
681493WW In distribution
681492WW In distribution
763423WW In distribution
666122WW In distribution
666065WW In distribution
666119WW In distribution
692424WW 3 In distribution
763422WW In distribution
672720WW In distribution
666129WW In distribution
666128WW In distribution
666121WW In distribution
666120WW In distribution
666130WW In distribution
666434WW In distribution
666119WW In distribution
666127WW In distribution
666066AN In distribution
666125WW In distribution
666433WW In distribution
666123WW In distribution
692425WW 3 In distribution
666118WW In distribution
762062WW In distribution
666121WW In distribution
666117WW In distribution
666130WW In distribution
666126WW In distribution
666117WW In distribution
666124WW In distribution
666124WW In distribution
692426WW 3 In distribution
687593WW Withdrawn
740234WW Withdrawn
687592WW Withdrawn
681493WW Withdrawn
704969WW Withdrawn
687592WW Withdrawn
681492WW Withdrawn
666125WW Withdrawn
740233WW Withdrawn
704794WW Withdrawn
687593WW Withdrawn
666066AN Withdrawn
666065WW Withdrawn
672720WW Withdrawn
666433WW Withdrawn
704967WW Withdrawn
666434WW 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
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