New CEN standard – EN ISO 4049:2019 – Dentistry – Polymer-based restorative materials 

Going to the dentist is, for many of us, rarely a pleasant experience. But no reason to be afraid: thanks to European standards, taking care of our teeth is as safe and risk-free as possible!

This is the case of newly approved EN ISO 4049 ‘Dentistry - Polymer-based restorative materials’. The new standard specifies requirements for dental polymer-based restorative materials used by the dentist in the mouth of the patient and intended for use primarily for the direct or indirect restoration of the teeth and for luting. The materials covered by the text of this standard are intended for use in the cementation or fixation of restorations and appliances such as inlays, onlays, veneers, crowns and bridges.

The story of EN ISO 4049’s approval and successful introduction at the European level is a good case of successful cooperation between the European and the international standardization systems. Indeed, EN ISO 4049 builds on a previously existing European Standard, EN ISO 4049:2009. In March 2015, the Council of European Dentists (CED, which represents over 300.000 dentists across Europe) requested CEN to improve EN ISO 4049 by requesting a material declaration from the manufacturer. The request to CEN was based on a growing debate on the toxicity of alternative dental restorative materials, based on the Minamata Convention on Mercury and the following revision of the EU Mercury Strategy.

After some discussions, CEN made the decision to proceed with the required modification and introduce a qualitative declaration of materials composition for materials used in dentistry. This decision was then forwarded to ISO for it to be adopted at the international level.

In the meantime, in 2017 the European approach was strengthened by the new EU Regulation 2017/745 on medical devices, which is due to enter into force by 2020. The Regulation demands manufacturers to specify the overall qualitative and quantitative information on the materials and substances to which patients can be exposed.

The official request from the EU institutions, together with CEN’s input, helped the work on the update of the standard to pick up steam at the ISO level. The resulting new EN ISO 4049 ensures the implementation of the Regulation by converting a general legal requirement into a specific material-oriented requirement. In particular, the text of the standards establishes in detail the information on the components present in the materials manufacturers shall provide. 

Due to its fruitful adoption and successful outcome, EN ISO 4049 will now serve as a model for several other similar material standards. Furthermore, its international application, based on a CEN input, is a good example of the ability of European standards and rules – and of the European Standardization System - to have an impact beyond the borders of the EU and EFTA countries. Most importantly, by making dental cures safer and minimizing the risks of allergy problems, this standard will benefit the most relevant people: patients.

EN ISO 4049 was developed and adopted by CEN/TC 55 ‘Dentistry’, whose Secretariat is currently held by DIN, the German National Standardization Body.

For more information, please contact Jennifer OGBONNA at CEN and CENELEC (jogbonna@cencenelec.eu) or Dr Hans-Peter KELLER at DIN (Hans-peter.Keller@din.de)