QUALITY & REGULATIONS


To us quality is meeting our customer’s needs and exceeding their expectations. We believe we are especially apt to that task due to our combination of clinical experience and manufacturing competence. We are very proud of our in-house manufacturing which is based in our production facility in Kongsvinger, Norway.

 

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 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. 

 Class IIa Class I

MALU

Hooks & stops

Estik Etch

Rotation wedges

Burs

Wires

Mini Lock

Retractors

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