O-Ties
O-Ties™ .120" Metallic Purple
36manufacturers in China registered for this device type
74catalogue 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 | 2017-09-08 |
| Record revised | 2025-12-30 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2020-07-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 400-757 | In distribution | |
| 400-764L | In distribution | |
| 400-776L | In distribution | |
| 400-785 | In distribution | |
| 400-755L | In distribution | |
| 400-753 | In distribution | |
| 400-758L | In distribution | |
| 400-796L | In distribution | |
| 400-780L | In distribution | |
| 400-751 | In distribution | |
| 400-790L | In distribution | |
| 400-757L | In distribution | |
| 400-760L | In distribution | |
| 400-775L | In distribution | |
| 400-783 | In distribution | |
| 400-774L | In distribution | |
| 400-774 | In distribution | |
| 400-760 | In distribution | |
| 400-794 | In distribution | |
| 400-754L | In distribution | |
| 400-752L | In distribution | |
| 400-759 | In distribution | |
| 400-781L | In distribution | |
| 400-782L | In distribution | |
| 400-777L | In distribution | |
| 400-778L | In distribution | |
| 400-769L | In distribution | |
| 400-792 | In distribution | |
| 400-783L | In distribution | |
| 400-756 | In distribution | |
| 400-759L | In distribution | |
| 400-775 | In distribution | |
| 400-784 | In distribution | |
| 400-787L | In distribution | |
| 400-752 | In distribution | |
| 400-794L | In distribution | |
| 400-791L | In distribution | |
| 400-777 | In distribution | |
| 400-758 | In distribution | |
| 400-792L | In distribution | |
| 400-753L | In distribution | |
| 400-762 | In distribution | |
| 400-786L | In distribution | |
| 400-795 | In distribution | |
| 400-770L | In distribution | |
| 400-755 | In distribution | |
| 400-771L | In distribution | |
| 400-793 | In distribution | |
| 400-762L | In distribution | |
| 400-779L | In distribution | |
| 400-782 | In distribution | |
| 400-785L | In distribution | |
| 400-784L | In distribution | |
| 400-793L | In distribution | |
| 400-769 | In distribution | |
| 400-756L | In distribution | |
| 400-763L | In distribution | |
| 400-795L | In distribution | |
| 400-754 | In distribution | |
| 400-763 | Withdrawn | |
| 400-751L | Withdrawn | |
| 400-764 | Withdrawn | |
| 400-780 | Withdrawn | |
| 400-779 | Withdrawn | |
| 400-770 | Withdrawn | |
| 400-776 | Withdrawn | |
| 400-778 | Withdrawn | |
| 400-781 | Withdrawn | |
| 400-787 | Withdrawn | |
| 400-791 | Withdrawn | |
| 400-790 | Withdrawn | |
| 400-786 | Withdrawn | |
| 400-771 | Withdrawn | |
| 400-796 | 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.