Data / Medical devices / Gutta-Percha

Gutta-Percha (EKM): 72 FDA-registered makers in 14 countries

72 establishments in 14 countries are registered with the FDA to make Gutta-Percha (product code EKM, Class 1, 21 CFR 872.3850). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 23 510(k) clearances under this code, the latest on February 27, 2008, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

EKM

Device class

1

Regulation

872.3850

Medical specialty

Dental

Makers by country

Makers of Gutta-Percha

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 February 27, 2008. 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.