Elastomeric Band
CLE 3/16" 5mm 6.0 X-Heavy (50 PK)
36manufacturers in China registered for this device type
58catalogue 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 | World Class Technology Corporation, United States |
|---|---|
| FDA product code | ECI |
| Device type | Band, Elastic, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-10-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 60.63.964.00035 | In distribution | |
| 60.63.936.00060 | In distribution | |
| 60.63.876.00060 | In distribution | |
| 60.63.873.31025 | In distribution | |
| 60.63.856.31060 | In distribution | |
| 60.63.864.00035 | In distribution | |
| 60.63.846.31060 | In distribution | |
| 60.63.853.31025 | In distribution | |
| 60.63.863.00025 | In distribution | |
| 60.63.946.00060 | In distribution | |
| 60.63.855.31045 | In distribution | |
| 60.63.866.31060 | In distribution | |
| 60.63.855.00045 | In distribution | |
| 60.63.854.31035 | In distribution | |
| 60.63.843.00025 | In distribution | |
| 60.63.874.31035 | In distribution | |
| 60.63.973.00025 | In distribution | |
| 60.63.854.00035 | In distribution | |
| 60.63.835.31045 | In distribution | |
| 60.63.836.00060 | In distribution | |
| 60.63.833.00025 | In distribution | |
| 60.63.865.31045 | In distribution | |
| 60.63.974.00035 | In distribution | |
| 60.63.966.00060 | In distribution | |
| 60.63.945.00045 | In distribution | |
| 60.63.975.00045 | In distribution | |
| 60.63.846.00060 | In distribution | |
| 60.63.935.00045 | In distribution | |
| 60.63.965.00045 | In distribution | |
| 60.63.874.00035 | In distribution | |
| 60.63.954.00035 | In distribution | |
| 60.63.845.00045 | In distribution | |
| 60.63.844.31035 | In distribution | |
| 60.63.866.00060 | In distribution | |
| 60.63.834.31035 | In distribution | |
| 60.63.834.00035 | In distribution | |
| 60.63.934.00035 | In distribution | |
| 60.63.835.00045 | In distribution | |
| 60.63.953.00025 | In distribution | |
| 60.63.836.31060 | In distribution | |
| 60.63.845.31045 | In distribution | |
| 60.63.976.00060 | In distribution | |
| 60.63.873.00025 | In distribution | |
| 60.63.856.00060 | In distribution | |
| 60.63.863.31025 | In distribution | |
| 60.63.833.31025 | In distribution | |
| 60.63.944.00035 | In distribution | |
| 60.63.865.00045 | In distribution | |
| 60.63.943.00025 | In distribution | |
| 60.63.876.31060 | In distribution | |
| 60.63.875.00045 | In distribution | |
| 60.63.864.31035 | In distribution | |
| 60.63.963.00025 | In distribution | |
| 60.63.933.00025 | In distribution | |
| 60.63.843.31025 | In distribution | |
| 60.63.955.00045 | In distribution | |
| 60.63.875.31045 | In distribution | |
| 60.63.844.00035 | In distribution |
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.