MARK3

Bite Registration Tray Sideless Post. 50/pk. - Cargus

Registry build 21.09.26
41manufacturers in China registered for this device type
10catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (11), Guangdong (8), Shanghai (4). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EBH
Manufacturer City Province Registered as Device types
BH Medical Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 37
Suzhou Pac-Dent Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 26
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Shanghai Jolly Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 99
Shanghai Lions Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 82
Zogear Medical Co., Ltd. Yizheng Jiangsu Contract manufacturer 75
Wuxi Lyusmile IMP AND EXP Co., Ltd. Wuxi Jiangsu Private-label distributor 66
Hubei Guarddent Medical Technology Co., Ltd. Wuhan Hubei Manufacturer 60
Anqing Clean Dental Instrument Technology Co., Ltd. Anqing Anhui Manufacturer 50
Dongguan Wanjin Industrial Co., Ltd. Dongguang Guangdong Remanufacturer 41
Tangshan Zhengtong Exhibition Co., Ltd. Tangshan Hebei Manufacturer 34
Tianjin Water Source Tech Co., Ltd. Tianjin Tianjin Manufacturer 27

Showing 12 of 41. All 41 manufacturers in China registered for Material, Impression Tray, Resin

Record

Regulatory record for MARK3
Listed by Cargus International, Inc
FDA product code EBH
Device type Material, Impression Tray, Resin
Device class Class 1
Regulation 21 CFR 872.3670
Premarket notification Exempt
Record published 2021-04-27

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Label carries lot or batch number, manufacturing date
Storage Special storage condition: Store in cool, dry place.

Catalogue Numbers

Catalogue numbers for MARK3
Catalogue number Size Per pack Status
0205CS 600 In distribution
0203 50 In distribution
0201CS 700 In distribution
0204CS 1,000 In distribution
0203CS 1,000 In distribution
0202 35 In distribution
0201 35 In distribution
0205 30 In distribution
0204 50 In distribution
0202CS 700 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
COE® GC America Inc. 400
Power Dental USA Power Dental U.S.A. Inc. 56
Plasdent Plasdent Corp. 41
JMU JMU Dental, Inc 40
Vertex-Dental BV Vertex-Dental B.V. 34
COE Tray Plastic™ GC America Inc. 28
Ou Nuo Changzhou OU NUO Medical Equipment Co., Ltd. 28
Excellent Plasdent Corp. 22
Shining 3D® Hangzhou SHINING3D Dental Technology Co., Ltd. 17
Smart Dent ® Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. 17
Britedent Bright Supply Inc 16
iSmile Ismile Dental Products Inc. 15

Showing 12 of 197. All products under Material, Impression Tray, 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