EU → North America Device Access

President Dental GmbH

DE-MF-000014901 · Germany · Allershausen

President Dental GmbH is registered in the European database on medical devices as a manufacturer, with 378 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa378

Most frequent device types declared: 1.

Among these devices, 5 are declared sterile, 294 implantable, 1 active.

Devices declared under this manufacturer

Showing 12 of 378 declared devices.

Catalogue references include PRD.01.100.ZBX.16, PRD.01.300.ZM18-C1, PRD.01.300.ZM20-D2, PRD.01.300.ZPS16-A3,5, PRD.01.300.ZPS22-B2, PRD.01.GMM01-15-40.

European nomenclature codes declared: Q01010199, Q01010103, Q01010401, Q01010403, Q0102050199, Q019002.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED378
Country of registrationGermany

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN378
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. President Dental GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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