EU → North America Device Access

Biotech Dental

FR-MF-000000669 · France · Salon de Provence

Biotech Dental is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa3
Class IIb4

Most frequent device types declared: PKCF1525.

Among these devices, 4 are declared implantable.

Devices declared under this manufacturer

Catalogue references include K30EXBSH, KEXBSH, PKCF00, PKCF1525, PKCF1525/6, PKCF3040.

European nomenclature codes declared: Q010599, Q010299, L159099.

United States market access

FDA establishment registerRegistered with FDA
Matched entryBIOTECH DENTAL SAS (FR) · FDA 3014290448
Devices in EUDAMED7
Country of registrationFrance

Device-level evidence

Devices with a numeric GTIN7
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: United States only. Biotech Dental is registered in the United States but was not found in the Canadian register.

Other manufacturers in France

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