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. The capability to analyse the cause of failure is essential to the systematic improvement of quality. In the face of market forces favouring interoperable components rather than a vertically integrated CAD/CAM system, this requirement places an increased responsibility on the dental office to use the comprehensive data generated by the CAD system to understand the reasons for a clinical failure or the need for rework of a prosthetic device, and to  prevent recurrence of the problem. Frequently, knowledge of the behaviour of materials both during production and in the finished prosthesis is needed in order to attain the necessary understanding of sub-optimal, clinical performance.

Digitalstyrt fremstilling av protetiske konstruksjoner på tannlegekontor – hvilke krav stilles?
Tibballs JE, Dahl BE.
Holmstrup P (ed.), Odontologi 2015
Aktuel Nordisk Odontologi, København, Munksgaard, 2015; pages 141–153