Data / Medical devices / Facebow / China
FDA-registered makers of Facebow in China: 5 establishments
5 establishments in China are registered with the FDA to make Facebow (product code KCR). 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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Makers of Facebow in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Astar Orthodontics Inc. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Cheer-U Material Technology Co., Ltd | Guangzhou Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Pengwu Medical Equipment Co.,ltd | Hangzhou Zhejiang, China | 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 | |
| Zhejiang Risheng Medical Technology Co., Ltd | Hangzhou 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.