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Data / Medical devices / Frame, Rubber Dam / China

FDA-registered makers of Frame, Rubber Dam in China: 6 establishments

6 establishments in China are registered with the FDA to make Frame, Rubber Dam (product code EJE). 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
Frame, Rubber Dam
Product code
EJE
Country
China

Makers of Frame, Rubber Dam in China

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Debo Medical Technology (shijiazhuang) Co., Ltd.Shijiazhuang Hebei, ChinaContract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Elite Dental LabHuizhou City Guangdong, ChinaManufacturer0000api.fda.gov
Huanghua Promisee Dental Co., LtdHuanghua Hebei, ChinaManufacturer0000api.fda.gov
Premium Plus (dongguan) LimitedDongguan Guangdong, ChinaManufacturer, Repackager or relabeler0000api.fda.gov
Shenzhen Yimi Care Technology Co.,ltdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
ZOGEAR Medical Co., Ltd.Yizheng Jiangsu, ChinaManufacturer0000api.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.