EU → North America Device Access

P.L. Superior Dental Materials GmbH

DE-MF-000005251 · Germany · Hamburg

P.L. Superior Dental Materials GmbH is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa7

Among these devices, 4 are declared implantable.

Devices declared under this manufacturer

Catalogue references include 1083415, 1083417, 33685, 76630, 785550, HE314.

European nomenclature codes declared: Q01020605, Q01010103, Q01010202, Q01010106.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED7
Country of registrationGermany

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

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. P.L. Superior Dental Materials GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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