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Data / Medical devices / Gutta-Percha / China

FDA-registered makers of Gutta-Percha in China: 38 establishments

38 establishments in China are registered with the FDA to make Gutta-Percha (product code EKM). 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
Gutta-Percha
Product code
EKM
Country
China

Makers of Gutta-Percha in China

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Anqing Clean Dental Instrument Technology Co.,ltdAnqing City Anhui, ChinaExporter to the US, Manufacturer0000api.fda.gov
Chengdu Sani Medical Equipment Co.,ltd.Chengdu Sichuan, ChinaExporter to the US, Manufacturer0000api.fda.gov
Debo Medical Technology (shijiazhuang) Co., Ltd.Shijiazhuang Hebei, ChinaContract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Dentsply Dental (tianjin) Co., Ltd.TEDA Tianjin, ChinaContract manufacturer0000api.fda.gov
Dongguan Integrity Medical Instrument Co.,ltd.Dongguan Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Foshan CICADA Dental Instrument Co., Ltd.Foshan Guangdong, ChinaManufacturer0000api.fda.gov
Gavin Biotechnology Co.,ltdJinzhong Shanxi, ChinaExporter to the US, Manufacturer0000api.fda.gov
Guilin Kevin Peter Technology Co., Ltd.Guilin Guangxi, ChinaManufacturer0000api.fda.gov
GUILIN YIKESHI Medical Device CO LTDGuilin Guangxi, ChinaManufacturer0000api.fda.gov
Hantech Medical Device Co., Ltd.Cixi Zhejiang, ChinaContract manufacturer0000api.fda.gov
Henan Baistra Medical Devices LimitedZhengzhou Henan, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hubei Guarddent Medical Technology Co.,ltdWuhan Hubei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Huizhou Videya Technology Co., Ltd.Huizhou Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Henan Lusterdent Medical Instrument Co.,LtdZhengzhou Henan, ChinaManufacturer0000api.fda.gov
Innovative Material & Devices, Inc.Wuxi Jiangsu, ChinaManufacturer0000api.fda.gov
Jiangsu Yida Medical Equipment Co., LtdYancheng Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Jining Orodeka Medical Equipment Co.,ltdJiNing Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shandong Hengfeng Kerui Medical Equipment Co., LtdQingdao City Shandong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Shandong Richsource Biological Technology Co.,ltdJining Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shanghai Alwings Medical Instrument Co.,ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Shanghai Dochem Industries Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Shanghai Lions Industrial Co.,ltd.Shanghai, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Shanghai Xing Yu Medical Equipment Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Shanwei Perfect Medical Instruments Co.,ltd.Shanwei Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Denco Medical Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Shenzhen Perfect Medical Instruments Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Rogin Medical Co., Ltdshenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Shenzhen Superline Technology Co.,ltdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Suzhou Ramo Medical Instrument Co., Ltd.Suzhou City Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shanghai Jolly Industrial Co., Ltd.Shanghai, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Tianjin Diadent Co., Ltd.Tianjin City, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Tianjin Gapadent Co., Ltd.Tianjin, ChinaManufacturer0000api.fda.gov
Tianjin Jieyaxin Medical Plastic Equipment Co., Ltd.Tianjin, ChinaManufacturer0000api.fda.gov
Tribest Dental Products Co LtdYangzhong Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
United Dental ChangzhouChangzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Univy Technology Advanced Co. LtdShanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Wellmed Dental Medical Supply Co., LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Xiantao S&J Protective Products Co., LtdXiantao Hubei, ChinaExporter to the US, Manufacturer0000api.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.