3D dental prostheses: FEPPD warns of the possible risks of "circumvention of the regulations on dental devices"
The development of new digital technologies has led to the emergence of new ways of manufacturing dental prostheses. Subject to important regulatory requirements, prosthetic technicians, through the Fédération Européenne des Patrons Prothésistes Dentaires (FEPPD) are demanding the application of uniform rules in the interests of the comfort, safety and health of patients.
The FEPPD is concerned that due to a revolution in the world of dental prosthesis technology: the development and increasing accessibility of new digital technologies (computer-aided design and printing and 3D printers) unregulated dental surgeons equipped with a 3D system can create directly, in their own practices, dental prostheses such as ceramic crowns.
Dental prosthetic technicians, the traditional makers of dental prosthetics, deplore the lack of precision in the European regulation on medical devices voted for by the European Parliament and which came into force on 27 May. At their general meeting on 2 and 3 June, representatives of the FEPPD launched an approach to the European Community aimed to ensure that whoever it may be (dental laboratory or dental surgeon in private practice), any dental prosthesis manufacturer must be subject to the same health rules as those which have long applied to professional prosthetic technicians: quality and traceability of materials, certification of conformity, etc.
Traceability of materials
Laurent Munerot, the president of the FEPPD, explains: "At a time when European citizens are increasingly demanding information about the origin of the food they consume and expect rigorously accurate information on this subject, it would be anachronistic that they should be deprived of essential information on the provenance and composition of dental devices intended to be implanted in their mouths for several decades. The new European regulation on medical devices is unclear on this subject. For the comfort, safety and health of all, we believe it is essential that this is clarified as soon as possible."
The manufacture of dental devices in the UK is regulated by the MHRA. Concern has also been raised by British dental technicians regarding the increasing number of unregulated members of the dental team manufacturing dental devices such as crowns, specialist dental trays and mouthguards.
Founded in 1953 under the original name Fédération internationale de la prothèse dentaire (The International Federation of Dental Prosthetics) the Fédération européenne et internationale des patrons prothésistes dentaires (European and International Federation of Dental Prosthetists) represents some 40,000 dental laboratories and 210,000 dental technicians operating in Europe. For more information visit www.feppd.eu.