Young Specialties

Orthodontic Latex-Free Neon Elastics 5/16" Medium (50 patient packs)

Registry build 21.09.26
36manufacturers in China registered for this device type
61catalogue 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 Young Specialties
Listed by Young Innovations Inc., United States
FDA product code ECI
Device type Band, Elastic, Orthodontic
Device class Class 1
Regulation 21 CFR 872.5410
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2022-11-02
Record revised 2023-03-21 (version 6)

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 Bag of 50, box of 50, inner pack of 50, inner pack
Distribution end date 2023-03-06

Catalogue Numbers

Catalogue numbers for Young Specialties
Catalogue number Size Status
701-070 In distribution
705-060 In distribution
705-030 In distribution
705-090 In distribution
706-030 In distribution
705-080 In distribution
701-085 In distribution
701-030 In distribution
705-085 In distribution
705-065 In distribution
706-100 In distribution
707-070 In distribution
706-095 In distribution
706-020 In distribution
705-025 In distribution
701-060 In distribution
701-015 In distribution
707-090 In distribution
701-010 In distribution
707-080 In distribution
707-075 In distribution
707-060 In distribution
705-105 In distribution
707-105 In distribution
707-085 In distribution
701-025 In distribution
707-065 In distribution
701-095 In distribution
707-025 In distribution
705-075 In distribution
701-100 In distribution
706-060 In distribution
705-095 In distribution
705-010 In distribution
706-025 In distribution
705-070 In distribution
701-075 In distribution
705-100 In distribution
701-020 In distribution
706-075 In distribution
705-015 In distribution
701-080 In distribution
707-010 In distribution
706-080 In distribution
706-090 In distribution
706-105 In distribution
707-020 In distribution
706-010 In distribution
705-020 In distribution
701-105 In distribution
701-090 In distribution
701-065 In distribution
706-015 In distribution
707-030 In distribution
707-100 In distribution
706-070 In distribution
707-015 In distribution
706-085 In distribution
707-095 In distribution
706-065 In distribution
701-090S Withdrawn

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