3m™ Unitek™

3M™ Unitek™ Elastics, 404-226, Medium-Light 3.5 oz, 3/16 in, Green (Dwight), 100/Pk, 30 Pk/Ct

Registry build 21.09.26
36manufacturers in China registered for this device type
67catalogue 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 3M™ Unitek™
Listed by 3M Unitek, United States
FDA product code ECI
Device type Band, Elastic, Orthodontic
Device class Class 1
Regulation 21 CFR 872.5410
Premarket notification Exempt
Record published 2022-12-08

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
Packaging Box of 30

Catalogue Numbers

Catalogue numbers for 3M™ Unitek™
Catalogue number Size Per pack Status
404-616 100 In distribution
404-156 100 In distribution
404-626 100 In distribution
390-150 10 In distribution
404-526 100 In distribution
404-756 100 In distribution
404-126 30 In distribution
404-636 100 In distribution
404-116 100 In distribution
404-236 100 In distribution
404-116 30 In distribution
404-716 100 In distribution
404-656 100 In distribution
404-626 100 In distribution
404-246 100 In distribution
404-426 100 In distribution
404-536 100 In distribution
404-276 100 In distribution
404-226 100 In distribution
404-656 100 In distribution
404-256 100 In distribution
404-726 100 In distribution
404-276 100 In distribution
404-216 100 In distribution
404-646 100 In distribution
407-120 In distribution
407-130 In distribution
404-166 100 In distribution
404-556 100 In distribution
404-746 100 In distribution
404-176 100 In distribution
404-266 100 In distribution
404-546 100 In distribution
404-146 30 In distribution
404-736 100 In distribution
404-136 100 In distribution
404-526 100 In distribution
404-236 100 In distribution
404-756 100 In distribution
404-166 100 In distribution
404-426 100 In distribution
404-536 100 In distribution
404-736 100 In distribution
404-266 100 In distribution
404-516 100 In distribution
404-136 30 In distribution
404-556 100 In distribution
404-146 100 In distribution
404-176 100 In distribution
404-726 100 In distribution
404-616 100 In distribution
404-636 100 In distribution
404-646 100 In distribution
404-516 100 In distribution
404-716 100 In distribution
407-125 In distribution
404-256 100 In distribution
404-546 100 In distribution
404-746 100 In distribution
404-126 100 In distribution
404-156 30 In distribution
404-226 100 In distribution
404-216 100 In distribution
407-030 In distribution
404-246 100 In distribution
407-020 In distribution
407-025 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