Data / Medical devices / Liner, Cavity, Calcium Hydroxide

Liner, Cavity, Calcium Hydroxide (EJK): 32 FDA-registered makers in 10 countries

32 establishments in 10 countries are registered with the FDA to make Liner, Cavity, Calcium Hydroxide (product code EJK, Class 2, 21 CFR 872.3250). 25 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 78 510(k) clearances under this code, the latest on July 21, 2026, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code

EJK

Device class

2

Regulation

872.3250

Medical specialty

Dental

Makers by country

Makers of Liner, Cavity, Calcium Hydroxide

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Updated July 21, 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.