E-Chain

Tooth-Colored Medium

Registry build 21.09.26
36manufacturers in China registered for this device type
92catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (14), Jiangsu (8), Shanghai (4). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code ECI
Manufacturer City Province Registered as Device types
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
Sino Ortho Limited Hangzhou Zhejiang Contract manufacturer 14
Hangzhou Westlake Biomaterial Co., Ltd. Hangzhou Zhejiang Contract manufacturer 13
Zhejiang Eksen Medical Technology Co., Ltd. Huzhou Zhejiang Contract manufacturer 9
Zhejiang Risheng Medical Technology Co., Ltd. Hangzhou Zhejiang Contract manufacturer 8
Yancheng Denrum Medical Apparatus Co., Ltd. Yancheng Jiangsu Contract manufacturer 5
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Zogear Medical Co., Ltd. Yizheng Jiangsu Contract manufacturer 75
Wuxi Lyusmile IMP AND EXP Co., Ltd. Wuxi Jiangsu Private-label distributor 66
Shanghai MU Promotions Co., Ltd. Shanghai Shanghai Exporter 62
Hubei Guarddent Medical Technology Co., Ltd. Wuhan Hubei Manufacturer 60
Tribest Dental Products Co Ltd Yangzhong Jiangsu Contract manufacturer 58

Showing 12 of 36. All 36 manufacturers in China registered for Band, Elastic, Orthodontic

Record

Regulatory record for E-Chain
Listed by TP Orthodontics, Inc., United States
FDA product code ECI
Device type Band, Elastic, Orthodontic
Device class Class 1
Regulation 21 CFR 872.5410
Establishment Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2021-02-15

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Label carries lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for E-Chain
Catalogue number Size Status
390-150 In distribution
389-067 In distribution
390-067 In distribution
388-063 In distribution
389-054 In distribution
388-065 In distribution
388-066 In distribution
389-060 In distribution
388-052 In distribution
390-154 In distribution
390-162 In distribution
390-157 In distribution
389-063 In distribution
390-071 In distribution
390-151 In distribution
390-058 In distribution
390-172 In distribution
389-055 In distribution
388-068 In distribution
388-067 In distribution
390-164 In distribution
390-057 In distribution
390-156 In distribution
389-050 In distribution
384-050 In distribution
390-168 In distribution
389-068 In distribution
390-050 In distribution
390-167 In distribution
390-066 In distribution
388-061 In distribution
390-153 In distribution
389-062 In distribution
390-170 In distribution
390-053 In distribution
390-055 In distribution
390-060 In distribution
390-169 In distribution
390-065 In distribution
388-053 In distribution
390-052 In distribution
389-057 In distribution
389-052 In distribution
389-071 In distribution
390-070 In distribution
389-066 In distribution
390-051 In distribution
389-064 In distribution
388-057 In distribution
388-064 In distribution
390-165 In distribution
390-061 In distribution
390-069 In distribution
390-068 In distribution
390-064 In distribution
389-061 In distribution
390-161 In distribution
388-051 In distribution
390-163 In distribution
388-054 In distribution
388-070 In distribution
385-050 In distribution
388-055 In distribution
390-062 In distribution
389-058 In distribution
390-159 In distribution
390-056 In distribution
388-071 In distribution
388-069 In distribution
390-152 In distribution
390-160 In distribution
390-166 In distribution
390-155 In distribution
388-062 In distribution
388-060 In distribution
390-158 In distribution
389-056 In distribution
390-059 In distribution
389-065 In distribution
390-054 In distribution
389-069 In distribution
389-051 In distribution
388-056 In distribution
388-058 In distribution
389-059 In distribution
390-063 In distribution
383-050 In distribution
389-053 In distribution
390-171 In distribution
389-070 In distribution
388-059 In distribution
388-050 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Auradonics Auradonics Incorporated 743
Advance Dental Products THE Atlanta Dental Supply Company 312
Conlin Molar Band Ortho Arch Company Inc 308
Elastic Chain Ortho Organizers, Inc. 248
Ligatures American Orthodontics 233
3M™ AlastiK™ 3M Unitek 220
Morelli Dental Morelli Ltda. 207
Mirabay Mirabay Orthodontics Corporation 185
Orthometric Elastomerics – Chain Orthometric – Industria E Comercio DE Produtos Medicos E Odontologicos Ltda 182
Maximum Ortho Technology, Inc. 177
Halo Molar Band Ortho Arch Company Inc 177
Colored Chain American Orthodontics 168

Showing 12 of 474. All products under Band, Elastic, Orthodontic

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