Data / Medical devices / Setter, Band, Orthodontic / China
FDA-registered makers of Setter, Band, Orthodontic in China: 8 establishments
8 establishments in China are registered with the FDA to make Setter, Band, Orthodontic (product code ECR). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Setter, Band, Orthodontic
- Product code
- ECR
- Country
- China
Makers of Setter, Band, Orthodontic in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Hangzhou Orthmay Advanced Materials Technology Co., Ltd | Hangzhou City Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Wise Medical Device Co.,ltd | Hangzhou Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huanghua Promisee Dental Co., Ltd | Huanghua Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthguide Medical Technology (jiangsu) Co., Ltd | Wuxi City Jiangsu, China | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qibei Technology Co., Limited | KL Hong Kong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Sunmc Dental Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Eksen Medical Technology Co., Ltd | Huzhou Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Protect Medical Equipment Co. Ltd. | Anji Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.