Orthometric Elastomerics – Chain

Orthometric Elastomerics-Elastic Chain 1,5M-MEDIUM-ASSORTMENT OF Colors

Registry build 21.09.26
36manufacturers in China registered for this device type
182catalogue 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 Orthometric Elastomerics – Chain
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 2022-09-28

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

Catalogue Numbers

Catalogue numbers for Orthometric Elastomerics – Chain
Catalogue number Size Status
60.05.6116 In distribution
60.05.7026 In distribution
60.05.6118 In distribution
60.05.6121 In distribution
60.05.5005 In distribution
60.05.6109 In distribution
60.05.6124 In distribution
60.05.6112 In distribution
60.05.5028 In distribution
60.05.5104 In distribution
60.05.5112 In distribution
60.05.5119 In distribution
60.05.7025 In distribution
60.05.7015 In distribution
60.05.7006 In distribution
60.05.6107 In distribution
60.05.7017 In distribution
60.05.7011 In distribution
60.05.7119 In distribution
60.05.7002 In distribution
60.05.7101 In distribution
60.05.6018 In distribution
60.05.6010 In distribution
60.05.7009 In distribution
60.05.7018 In distribution
60.05.7125 In distribution
60.05.6120 In distribution
60.05.7115 In distribution
60.05.6122 In distribution
60.05.6106 In distribution
60.05.5120 In distribution
60.05.6128 In distribution
60.05.6115 In distribution
60.05.6111 In distribution
60.05.6032 In distribution
60.05.7120 In distribution
60.05.7116 In distribution
60.05.7030 In distribution
60.05.5126 In distribution
60.05.5015 In distribution
60.05.5114 In distribution
60.05.7020 In distribution
60.05.6113 In distribution
60.05.7117 In distribution
60.05.5007 In distribution
60.05.5013 In distribution
60.05.6117 In distribution
60.05.6027 In distribution
60.05.7104 In distribution
60.05.7128 In distribution
60.05.5124 In distribution
60.05.5123 In distribution
60.05.7112 In distribution
60.05.6025 In distribution
60.05.5017 In distribution
60.05.7013 In distribution
60.05.7113 In distribution
60.05.6012 In distribution
60.05.5113 In distribution
60.05.6031 In distribution
60.05.5003 In distribution
60.05.7111 In distribution
60.05.5115 In distribution
60.05.6125 In distribution
60.05.5011 In distribution
60.05.5006 In distribution
60.05.5030 In distribution
60.05.7109 In distribution
60.05.6002 In distribution
60.05.5002 In distribution
60.05.5012 In distribution
60.05.6013 In distribution
60.05.6126 In distribution
60.05.7004 In distribution
60.05.5127 In distribution
60.05.7021 In distribution
60.05.5010 In distribution
60.05.7016 In distribution
60.05.6021 In distribution
60.05.7124 In distribution
60.05.7019 In distribution
60.05.7122 In distribution
60.05.7121 In distribution
60.05.6005 In distribution
60.05.6026 In distribution
60.05.7012 In distribution
60.05.6024 In distribution
60.05.5102 In distribution
60.05.7127 In distribution
60.05.6104 In distribution
60.05.7105 In distribution
60.05.5004 In distribution
60.05.7008 In distribution
60.05.6014 In distribution
60.05.7106 In distribution
60.05.5107 In distribution
60.05.5025 In distribution
60.05.5106 In distribution
60.05.5121 In distribution
60.05.7001 In distribution
60.05.6130 In distribution
60.05.5024 In distribution
60.05.5108 In distribution
60.05.6123 In distribution
60.05.5020 In distribution
60.05.6020 In distribution
60.05.6127 In distribution
60.05.6016 In distribution
60.05.6019 In distribution
60.05.6008 In distribution
60.05.7027 In distribution
60.05.5105 In distribution
60.05.5016 In distribution
60.05.6108 In distribution
60.05.7007 In distribution
60.05.5118 In distribution
60.05.7029 In distribution
60.05.5117 In distribution
60.05.6022 In distribution
60.05.7114 In distribution
60.05.5001 In distribution
60.05.5029 In distribution
60.05.7130 In distribution
60.05.5021 In distribution
60.05.5122 In distribution
60.05.7102 In distribution
60.05.5018 In distribution
60.05.7107 In distribution
60.05.5111 In distribution
60.05.5027 In distribution
60.05.7003 In distribution
60.05.6009 In distribution
60.05.5109 In distribution
60.05.5009 In distribution
60.05.5129 In distribution
60.05.6101 In distribution
60.05.6003 In distribution
60.05.7028 In distribution
60.05.6110 In distribution
60.05.6004 In distribution
60.05.5022 In distribution
60.05.5101 In distribution
60.05.7123 In distribution
60.05.5103 In distribution
60.05.6103 In distribution
60.05.6001 In distribution
60.05.7103 In distribution
60.05.5110 In distribution
60.05.7010 In distribution
60.05.7126 In distribution
60.05.6114 In distribution
60.05.5128 In distribution
60.05.5130 In distribution
60.05.7024 In distribution
60.05.7129 In distribution
60.05.5023 In distribution
60.05.6102 In distribution
60.05.7022 In distribution
60.05.5125 In distribution
60.05.6007 In distribution
60.05.7108 In distribution
60.05.7014 In distribution
60.05.6015 In distribution
60.05.5014 In distribution
60.05.6105 In distribution
60.05.7118 In distribution
60.05.7005 In distribution
60.05.6129 In distribution
60.05.5116 In distribution
60.05.6017 In distribution
60.05.6119 In distribution
60.05.6011 In distribution
60.05.6030 In distribution
60.05.7023 In distribution
60.05.6023 In distribution
60.05.5008 In distribution
60.05.5026 In distribution
60.05.5019 In distribution
60.05.7110 In distribution
60.05.6029 In distribution
60.05.6006 In distribution
60.05.6028 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
Maximum Ortho Technology, Inc. 177
Halo Molar Band Ortho Arch Company Inc 177
Colored Chain American Orthodontics 168
The Orthodontic Store Young Innovations Inc. 155

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