EU → North America Device Access

CMS Dental

DK-MF-000020260 · Denmark · Roslev

CMS Dental is registered in the European database on medical devices as a manufacturer, with 64 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa64

Most frequent device types declared: Cure and Photosensitizer Lights, Curing Lights, Photosensitizer Lights, Photosensitizers, ProlacSan Gel.

Among these devices, 5 are declared active.

Devices declared under this manufacturer

Showing 12 of 64 declared devices.

Catalogue references include 100403, 102400/AST0025620, 215510, OSOTWE/100, OSOTWE/135, OSR20/20.

European nomenclature codes declared: Q01010299, Q0199, Q010507.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED64
Country of registrationDenmark

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

Device-level evidence

Devices with a numeric GTIN64
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryCMS DENTAL APS

North American profile: Canada only. CMS Dental holds a Canadian licence but was not found in the U.S. register.

Other manufacturers in Denmark

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