Data / Medical devices / Handpiece, Direct Drive, Ac-Powered / China
FDA-registered makers of Handpiece, Direct Drive, Ac-Powered in China: 10 establishments
10 establishments in China are registered with the FDA to make Handpiece, Direct Drive, Ac-Powered (product code EKX). 8 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
- Handpiece, Direct Drive, Ac-Powered
- Product code
- EKX
- Country
- China
Makers of Handpiece, Direct Drive, Ac-Powered in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Guilin Woodpecker Medical Instrument Co., Ltd | GUILIN CITY Guangxi, China | Manufacturer | 2 | December 17, 2021 | 0 | 0 | 0 | api.fda.gov |
| Changzhou Bomedent Medical Technology Co., Ltd | Changzhou Jiangsu, China | Manufacturer | 1 | June 30, 2020 | 0 | 0 | 0 | api.fda.gov |
| Changzhou Sifary Medical Technology Co., Ltd. | Changzhou Jiangsu, China | Manufacturer | 1 | January 29, 2021 | 0 | 0 | 0 | api.fda.gov |
| Foshan Coxo Medical Instrument Co., Ltd. | Foshan Guangdong, China | Manufacturer | 1 | May 18, 2023 | 0 | 0 | 0 | api.fda.gov |
| Foshan CICADA Dental Instrument Co., Ltd. | Foshan Guangdong, China | Manufacturer | 1 | March 12, 2021 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Perfect Medical Instruments Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 1 | April 26, 2023 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Rogin Medical Co., Ltd | shenzhen Guangdong, China | Exporter to the US, Manufacturer | 1 | April 24, 2025 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Superline Technology Co.,ltd | Shenzhen Guangdong, China | Manufacturer | 1 | October 16, 2025 | 0 | 0 | 0 | api.fda.gov |
| Denjoy Dental Co., Ltd | Changsha city Hunan, China | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jung Chen Technology Co., Ltd. | Zhuhai Guangdong, China | Contract 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.