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Data / Medical devices / Agent, Tooth Bonding, Resin / China

FDA-registered makers of Agent, Tooth Bonding, Resin in China: 5 establishments

5 establishments in China are registered with the FDA to make Agent, Tooth Bonding, Resin (product code KLE). 5 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
Agent, Tooth Bonding, Resin
Product code
KLE
Country
China

Makers of Agent, Tooth Bonding, Resin in China

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Rizhao Huge Biomaterials Company, Ltd.Rizhao Shandong, ChinaManufacturer4December 20, 2024000api.fda.gov
Cao (china) Medical Equipment Company, LimitedLangfang, Hebei, ChinaContract manufacturer, Manufacturer2October 21, 2009000api.fda.gov
Liaoning Upcera Co.,LtdBenxi Liaoning, ChinaManufacturer1October 2, 2024000api.fda.gov
Sincera Technology (changchun) Co., LtdChangchun City Jilin, ChinaManufacturer1July 16, 2024000api.fda.gov
Sino-Dentex Co.,ltdChangchun Jilin, ChinaManufacturer1September 22, 2023000api.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.