Dispense-A-Tie Ligatures

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Registry build 21.09.26
36manufacturers in China registered for this device type
10catalogue 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 Dispense-A-Tie Ligatures
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
Record revised 2021-06-22 (version 2)

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 Dispense-A-Tie Ligatures
Catalogue number Size Status
383-013 In distribution
383-020 In distribution
383-009 In distribution
383-004 In distribution
383-011 In distribution
383-002 In distribution
383-005 In distribution
383-008 In distribution
383-007 In distribution
383-001 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