Unicycle™
Unicycle™ .120" Ligature Ties - Glow Bright Blue
36manufacturers in China registered for this device type
46catalogue 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.
| 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
| Listed by | Ortho Organizers, 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, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-10-08 |
| Record revised | 2025-12-30 (version 7) |
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 |
| Distribution end date | 2020-07-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4119-866 | In distribution | |
| 4119-844 | In distribution | |
| 4119-847 | In distribution | |
| 4119-867 | In distribution | |
| 4119-519 | In distribution | |
| 4119-907 | In distribution | |
| 4119-901 | In distribution | |
| 4119-870 | In distribution | |
| 4119-909 | In distribution | |
| 4119-848 | In distribution | |
| 4119-906 | In distribution | |
| 4119-520 | In distribution | |
| 4119-861 | In distribution | |
| 4119-842 | In distribution | |
| 4119-869 | In distribution | |
| 4119-878 | In distribution | |
| 4119-888 | In distribution | |
| 4119-884 | In distribution | |
| 4119-523 | In distribution | |
| 4119-852 | In distribution | |
| 4119-873 | In distribution | |
| 4119-526 | In distribution | |
| 4119-862 | In distribution | |
| 4119-882 | In distribution | |
| 4119-840 | In distribution | |
| 4119-886 | In distribution | |
| 4119-860 | In distribution | |
| 4119-843 | In distribution | |
| 4119-904 | In distribution | |
| 4119-903 | In distribution | |
| 4119-889 | In distribution | |
| 4119-874 | In distribution | |
| 4119-850 | In distribution | |
| 4119-522 | In distribution | |
| 4119-592 | In distribution | |
| 4119-892 | In distribution | |
| 4119-885 | In distribution | |
| 4119-845 | In distribution | |
| 4119-864 | In distribution | |
| 4119-846 | In distribution | |
| 4119-865 | In distribution | |
| 4119-905 | Withdrawn | |
| 4119-849 | Withdrawn | |
| 4119-524 | Withdrawn | |
| 4119-883 | Withdrawn | |
| 4119-851 | Withdrawn |
Same 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.