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Data / Medical devices / Sealant, Pit And Fissure, And Conditioner / Germany

FDA-registered makers of Sealant, Pit And Fissure, And Conditioner in Germany: 8 establishments

8 establishments in Germany are registered with the FDA to make Sealant, Pit And Fissure, And Conditioner (product code EBC). 4 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
Sealant, Pit And Fissure, And Conditioner
Product code
EBC
Country
Germany

Makers of Sealant, Pit And Fissure, And Conditioner in Germany

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Voco GMBHCUXHAVEN Lower Saxony, GermanyManufacturer3February 11, 2014000api.fda.gov
DMG Chemisch Pharmazeutische Fabrik GMBHHamburg, GermanyManufacturer2March 26, 2010000api.fda.gov
indigodental GmbHPinneberg Schleswig-Holstein, GermanyExporter to the US, Manufacturer2March 8, 1996000api.fda.gov
Deltamed GMBHFRIEDBERG Hesse, GermanyManufacturer1December 1, 2004000api.fda.gov
Identa Dental Material GMBHCUXHAVEN Lower Saxony, GermanyContract manufacturer0000api.fda.gov
Kulzer GMBHHANAU Hesse, GermanySpecification developer0000api.fda.gov
Kulzer GMBHWEHRHEIM Hesse, GermanyContract manufacturer0000api.fda.gov
S & C Polymer GMBHELMSHORN Schleswig-Holstein, GermanyContract manufacturer0000api.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.