Data / Medical devices / Unit, Operative Dental / China
FDA-registered makers of Unit, Operative Dental in China: 14 establishments
14 establishments in China are registered with the FDA to make Unit, Operative Dental (product code EIA). 12 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
- Unit, Operative Dental
- Product code
- EIA
- Country
- China
Makers of Unit, Operative Dental in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Lakong Medical Devices Co., Ltd. | Dongguan Guangdong, China | Manufacturer, Remanufacturer | 2 | August 7, 2026 | 0 | 0 | 0 | api.fda.gov |
| Sinol Dental Limited | Xianyang Shaanxi, China | Manufacturer | 2 | July 26, 2013 | 0 | 0 | 0 | api.fda.gov |
| FDC Technology Industry Company | Taishan,GUANG CHONG Guangdong, China | Exporter to the US, Manufacturer | 1 | January 27, 2025 | 0 | 0 | 0 | api.fda.gov |
| Foshan Gladent Medical Instrument Co.,ltd. | Foshan Guangdong, China | Exporter to the US, Manufacturer | 1 | November 15, 2006 | 0 | 0 | 0 | api.fda.gov |
| Foshan Safety Medical Equipment Co.,ltd. | China Guangdong, China | Manufacturer | 1 | February 28, 2024 | 0 | 0 | 0 | api.fda.gov |
| Guangdong Yadeng Medical Apparatus Co.,ltd | Foshan Guangdong, China | Manufacturer | 1 | June 27, 2025 | 0 | 0 | 0 | api.fda.gov |
| Guangzhou Ajax Medical Equipment Co Ltd | Guangzhou Guangdong, China | Manufacturer | 1 | September 5, 2014 | 0 | 0 | 0 | api.fda.gov |
| Jiangsu Dynamic Medical Technology Co., Ltd | Suzhou Jiangsu, China | Exporter to the US, Manufacturer | 1 | December 2, 2011 | 0 | 0 | 0 | api.fda.gov |
| Mipont Medical Equipment Co., Ltd. | guangzhou Guangdong, China | Manufacturer | 1 | May 27, 2025 | 0 | 0 | 0 | api.fda.gov |
| Shanghai Dental Instrument Factory Co., Ltd. | Shanghai, China | Manufacturer | 1 | November 15, 2006 | 0 | 0 | 0 | api.fda.gov |
| Shanghai Fimet Medical Instrument Co., Ltd. | Shang hai Shanghai, China | Manufacturer | 1 | November 1, 2005 | 0 | 0 | 0 | api.fda.gov |
| Zhuhai Siger Medical Equipment Co Ltd | Zhuhai Guangdong, China | Manufacturer | 1 | March 13, 2015 | 0 | 0 | 0 | api.fda.gov |
| Acot Plastics (xiamen) Co., Ltd. | XIAMEN Fujian, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carestream Healthcare International Company, Ltd | Shanghai, 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.