Data / Medical devices / Implant, Endosseous, Root-Form

Implant, Endosseous, Root-Form (DZE): 264 FDA-registered makers in 26 countries

264 establishments in 26 countries are registered with the FDA to make Implant, Endosseous, Root-Form (product code DZE, Class 2, 21 CFR 872.3640). 191 of them have a 510(k) clearance or PMA approval on file and 13 have a recall event. The FDA has issued 1,550 510(k) clearances under this code, the latest on October 22, 2026, and lists 110 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

DZE

Device class

2

Regulation

872.3640

Medical specialty

Dental

Implant

Yes

Makers by country

Makers of Implant, Endosseous, Root-Form

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 October 22, 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.