MARK3

eXact VPS Impression Material Monophase Regular Set 50ml. Cartridges 180/cs. - MARK3

Registry build 21.09.26
6manufacturers in China registered for this device type
75catalogue numbers in this listing

Who Else Makes It

Concentrated in Henan (1), Shandong (1), Jiangxi (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code ELW
Manufacturer City Province Registered as Device types
Hygedent Inc. Beijing Beijing Contract manufacturer 1
Zhengzhou Huaer Electro-Optics Technology Co., Ltd. Zhengzhou Henan Contract manufacturer 21
Shandong Huge Dental Material Corporation Rizhao Shandong Manufacturer 17
Jiangxi Dentalbright Technology Co., Ltd. Jiujiang Jiangxi Contract manufacturer 12
Sunrise Dental Laboratory, Ltd. Kowloon Hong Kong Manufacturer 5
Chemoment Materials Co., Ltd. Hefei Anhui Manufacturer 3

Record

Regulatory record for MARK3
Listed by Cargus International, Inc
FDA product code ELW
Device type Material, Impression
Device class Class 2
Regulation 21 CFR 872.3660
Record published 2016-10-05
Record revised 2023-07-26 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied as a kit Yes
Latex Contains natural rubber latex
Label carries lot or batch number, expiry date, manufacturing date
Storage Storage environment temperature 50 to 72 °F
Packaging Box of 2, box of 4, case of 100, box of 100, case of 12, box of 8

Catalogue Numbers

Catalogue numbers for MARK3
Catalogue number Size Per pack Status
3012 4 In distribution
0221 In distribution
1146 4 In distribution
1176 2 In distribution
0222BULK 100 In distribution
3016 4 In distribution
1177 In distribution
1146BULK 180 In distribution
0219-4 4 In distribution
0218BULK 100 In distribution
0220Bulk 100 In distribution
3025 2 In distribution
9021 In distribution
3011BULK 100 In distribution
1176 2 In distribution
1145BULK 180 In distribution
0221 2 In distribution
0221BULK 100 In distribution
3010BULK 100 In distribution
1170 2 In distribution
1141 4 In distribution
3026 2 In distribution
0220 2 In distribution
1147 4 In distribution
3012BULK 100 In distribution
1145 4 In distribution
3014 4 In distribution
3010 4 In distribution
3004 In distribution
9010 8 In distribution
0225BULK 100 In distribution
11401 4 In distribution
3027 2 In distribution
3011 4 In distribution
1140BULK 180 In distribution
0223 2 In distribution
3013BULK 100 In distribution
3017BULK 100 In distribution
3000 In distribution
1142BULK 180 In distribution
1153 2 In distribution
1147BULK 180 In distribution
3013 4 In distribution
0220-4 4 In distribution
0222 2 In distribution
1171 2 In distribution
0219 2 In distribution
9012 8 In distribution
0218 2 In distribution
1144 4 In distribution
9003 8 In distribution
3005 In distribution
0225 2 In distribution
0218-4 4 In distribution
0219BULK 100 In distribution
0224 2 In distribution
3016BULK 100 In distribution
3017 4 In distribution
0223BULK 100 In distribution
1143 4 In distribution
3015 4 In distribution
1151 2 In distribution
1161 In distribution
1144BULK 180 In distribution
9013 2 In distribution
3015BULK 100 In distribution
1141BULK 180 In distribution
1142 4 In distribution
1143BULK 180 In distribution
1150 2 In distribution
1173 2 In distribution
1172 2 In distribution
3014BULK 100 In distribution
9001 4 In distribution
0224BULK 100 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Henry Schein Henry Schein, Inc. 164
Darby Dental Supply, LLC Darby Dental Supply, LLC 124
EXAlence™ GC America Inc. 96
Panasil Kettenbach Gmbh & Co KG 73
Aquasil Ultra Smart Wetting® Impression Material Cartridge System Dentsply LLC 72
DentMix IPB Inc 70
Affinis Coltène/Whaledent AG 67
Take 1 Advanced Kerr Corporation 54
MDC Dental MDC Dental 49
Elastomeric Impression Material Shandong Huge Dental Material Corporation 46
Splash® DEN-MAT Holdings, LLC 44
Futar Kettenbach Gmbh & Co KG 42

Showing 12 of 1,245. All products under Material, Impression

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