With equipment for computer-aided design and manufacturing (CAD/CAM) in the dental office, the dentist again becomes his own dental technician. While the equipment itself is not subject to health-related regulation, the European Medical Devices Directive imposes requirements on the prosthodontic devices it produces. As a manufacturer of custom-made, medical devices, the dental office is required to document its ability to ensure that the produced prostheses function satisfactorily, and that any failure to meet the defined quality criteria is followed up systematically.
Digitalstyrt fremstilling av protetiske konstruksjoner på tannlegekontor – hvilke krav stilles?
Tibballs JE, Dahl BE.
In: Holmstrup P (ed.), Odontologi 2015 – Aktuel Nordisk Odontologi, København, Munksgaard, 2015; pages 141–153