EU → North America Device Access

Dent-A-Pharm Produktionsgesellschaft mbH

DE-MF-000012922 · Germany · Barmstedt

Dent-A-Pharm Produktionsgesellschaft mbH is registered in the European database on medical devices as a manufacturer, with 358 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa358

Most frequent device types declared: Bonding, self-etching, Etching Gel, Fissure Sealing, Flouride Varnish, Light Curing Cavity Liner.

Among these devices, 144 are declared implantable.

Devices declared under this manufacturer

Showing 12 of 358 declared devices.

Catalogue references include 04001, 12030012, 701057, 9813, C610011, W4004.

European nomenclature codes declared: Q010503, Q01010103, Q01010199, Q010204, Q01010104, Z12119007.

United States market access

FDA establishment registerRegistered with FDA
Matched entryDENT A PHARM PRODUKTIONSGESELLSCHAFT MBH (DE) · FDA 3009509745
Devices in EUDAMED358
Country of registrationGermany

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: United States only. Dent-A-Pharm Produktionsgesellschaft mbH is registered in the United States but was not found in the Canadian register.

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