Your guide to material selection

Nearly all dental materials are included in the legal term «medical devices».

The CE-mark is basically a trade passport to ensure free movement of goods
within the EU

Like it or not – regulatory issues affect the materials and devices offered to us on the European market. Our new webinar, now available on NIOMs YouTube channel, addresses some of the terminology in the regulations that lead to CE-marking of “medical devices”.

The requirements for the mandatory CE-marking are still quite general, so we need to use additional means when selecting a material. That could for example be screening of literature, obtaining in-depth information from manufacturers, or sharing clinical experience, as Gjerdet explains in the webinar.

Gjerdet strongly urges all professionals to be conscientious about the following:

Report unusual material behavior to the manufacturer. It is a responsibility to report, by the web pages or otherwise, issues with a material, so the products can be improved.
The direction for use is a part of the product. The directions for use should be adhered to. It is our responsibility, as clinicians and technicians, to do so in order to maintain material properties as intended by the manufacturer.

Education points As a side note, we’d like to remind all dentists in Norway, Denmark and Iceland that you get continuing educations points if you watch the webinar live. Our webinars are free, and we release approximately three every year.

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Figure 1: Examples of Class II materials typically encompass the filling materials and prosthetic materials.

NIOM Newsletter April/May 2019

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