EU → US Device Access

Dent4you GmbH

DE-MF-000006095 · Germany · Langenau

Dent4you GmbH is registered in the European database on medical devices as a manufacturer, with 100 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa100

Most frequent device types declared: Guttapercha Points, Paper Points, Dental roll, Articulating paper, Cotton pellets.

Among these devices, 22 are declared sterile, 49 implantable.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerRegistered with FDA
Matched entryDENT4YOU AG (CH) · FDA 3022516928
Devices in EUDAMED100
Country of registrationGermany

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