QUALITY & REGULATIONS

The in-house factor, and our long experience with product development and clinical use, has proved to be a winning formula for us. We simply believe this gives us an edge in meeting our customers’ requirements for high quality products.
Certificates
MDD & MDR Declarations of conformity
Click the name of the product family to access the declaration of conformity according to Annex II Excluding section 4 of Council Directive of 93/42/EEC on medical devices, as amended. All class I our products meet the MDR.
Class IIa | Class I |
Retainer boxes Napkin holders Mirrors Impression trays |
ADVERSE EVENTS
If you have experienced an adverse event with any of our products please contact us immediately at +47 628 14 898