EU → North America Device Access

KaVo Dental GmbH

DE-MF-000006471 · Germany · Biberach

KaVo Dental GmbH is registered in the European database on medical devices as a manufacturer, with 311 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa311

Among these devices, 283 are declared active.

Catalogue references include 0.571.0422, 1.000.4246, 1.006.1973, 1.006.4600, 1.007.5560, 1.009.1010.

European nomenclature codes declared: Z12119099, Z12110102, Z12110101, Q01010403, Z12119007, Q010401.

United States market access

FDA establishment registerRegistered with FDA
Matched entryKAVO DENTAL GMBH (DE) · FDA 3003637274
Devices in EUDAMED311
Country of registrationGermany

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryKAVO DENTAL GMBH

What it holds in Canada

Licences on record11
Currently active0
Class 2 devices11
First licensed1999-06-29

Licence types: Device Family (6), System (3), Device Group Family (2).

Licensed under: KAVO DENTAL HANDPIECES, KAVO RONDOFLEX, DIAGNODENT PEN, PIEZOLUX DENTAL SCALER, ARCUSDIGMA, KAVO COMPOSITE HANDPIECE.

North American profile: Both markets. KaVo Dental GmbH is registered in both the United States and Canada.

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