EU → North America Device Access

Schütz Dental GmbH

DE-MF-000013721 · Germany · Rosbach

Schütz Dental GmbH is registered in the European database on medical devices as a manufacturer, with 135 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa135

Most frequent device types declared: After-Bleaching, Dentales Bleichmaterial, Lichthärtender Dental Dam, Werkzeug für das IMPLA-Implantatsystem 004, Werkzeug für das IMPLA-Implantatsystem 005.

Devices declared under this manufacturer

Showing 12 of 135 declared devices.

Catalogue references include 635119, 637104, 638203, 638341, 638672, 638679.

European nomenclature codes declared: P01020180, Q0199.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED135
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. Schütz Dental GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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