PRO-Chain

Orthodontic Elastomeric ligature chain Continuous 15 ft / spool

Registry build 21.09.26
36manufacturers in China registered for this device type
58catalogue 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 PRO-Chain
Listed by Ortho Pro Dent LLC, United States
FDA product code ECI
Device type Band, Elastic, Orthodontic
Device class Class 1
Regulation 21 CFR 872.5410
Establishment Repacker / relabeller
Premarket notification Exempt
Record published 2024-11-04
Record revised 2024-11-05 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Latex Contains natural rubber latex
Label carries lot or batch number, expiry date, manufacturing date, serial number
Storage Storage environment temperature up to 25 °C

Catalogue Numbers

Catalogue numbers for PRO-Chain
Catalogue number Size Status
M15-910 In distribution
M12-912 In distribution
M07-910 In distribution
M12-911 In distribution
M09-912 In distribution
M00-912 In distribution
M12-910 In distribution
M07-911 In distribution
M14-912 In distribution
M05-912 In distribution
M06-912 In distribution
M17-912 In distribution
M00-910 In distribution
M10-910 In distribution
M02-911 In distribution
M07-912 In distribution
M19-911 In distribution
M03-912 In distribution
M14-911 In distribution
M16-910 In distribution
M08-911 In distribution
M11-911 In distribution
M17-910 In distribution
M01-910 In distribution
M15-912 In distribution
M09-910 In distribution
M13-912 In distribution
M02-912 In distribution
M01-912 In distribution
M16-912 In distribution
M00-910 In distribution
M06-911 In distribution
M13-910 In distribution
M08-912 In distribution
M13-911 In distribution
M04-910 In distribution
M03-910 In distribution
M04-912 In distribution
M17-911 In distribution
M03-911 In distribution
M11-912 In distribution
M10-912 In distribution
M15-911 In distribution
M16-911 In distribution
M00-911 In distribution
M14-910 In distribution
M04-911 In distribution
M01-911 In distribution
M11-910 In distribution
M05-911 In distribution
M02-910 In distribution
M19-912 In distribution
M09-911 In distribution
M19-910 In distribution
M06-910 In distribution
M05-910 In distribution
M08-910 In distribution
M10-911 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