Orthoflexy Elastomeric – Modular Ligature 10 Ties – Lime Green

Orthoflexy Elastomeric - Modular Ligature 10 Ties - Caribbean Blue

Registry build 21.09.26
36manufacturers in China registered for this device type
33catalogue 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 Orthoflexy Elastomeric – Modular Ligature 10 Ties – Lime Green
Listed by Orthometric – Industria E Comercio DE Produtos Medicos E Odontologicos Ltda
FDA product code ECI
Device type Band, Elastic, Orthodontic
Device class Class 1
Regulation 21 CFR 872.5410
Premarket notification Exempt
Record published 2025-11-20

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Orthoflexy Elastomeric – Modular Ligature 10 Ties – Lime Green
Catalogue number Size Status
60.06.1136 In distribution
60.06.1121 In distribution
60.06.1135 In distribution
60.06.1132 In distribution
60.06.1125 In distribution
60.06.1101 In distribution
60.06.1153 In distribution
60.06.1118 In distribution
60.06.1150 In distribution
60.06.1124 In distribution
60.06.1128 In distribution
60.06.1129 In distribution
60.06.1102 In distribution
60.06.1116 In distribution
60.06.1104 In distribution
60.06.1159 In distribution
60.06.1131 In distribution
60.06.1134 In distribution
60.06.1157 In distribution
60.06.1120 In distribution
60.06.1158 In distribution
60.06.1130 In distribution
60.06.1117 In distribution
60.06.1133 In distribution
60.06.1155 In distribution
60.06.1160 In distribution
60.06.1137 In distribution
60.06.1127 In distribution
60.06.1156 In distribution
60.06.1105 In distribution
60.06.1122 In distribution
60.06.1151 In distribution
60.06.1103 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