EU → US Device Access

Dent4You AG

CH-MF-000028926 · Switzerland · Heerbrugg

Dent4You AG is registered in the European database on medical devices as a manufacturer, with 1 943 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa1 943

Most frequent device types declared: DIATECH Diamond Instruments, Kenda Polishers, BRILLIANT EverGlow, BRILLIANT Crios, Impression Material.

Among these devices, 232 are declared implantable, 1 469 reusable, 86 active.

Authorised representative in the Union: DE-AR-000005719.

United States market access

FDA establishment registerRegistered with FDA
Matched entryDENT4YOU AG (CH) · FDA 3022516928
Devices in EUDAMED1 943
Country of registrationSwitzerland

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