Dental implant bodies, abutments, and ready-made superstructures (e.g. abutment cylinders) are medical devices, and are regulated by the Pharmaceutical and Medical Devices Act.

On the other hand, custom-made superstructures (e.g. implant prostheses) made by dental technicians are not medical devices, but the materials and instruments used by dental technicians are medical devices. Dental technicians and the process of making custom-made products are regulated by the Dental Technicians Act.

Each Act targets different products. But, in dental implant surgery, both medical devices and custom-made prostheses are used in combination. Moreover, some of the abutments are approved as devices which can be customized for patients.

This article explains the Japanese regulation of medical devices, especially those used for dental implant surgery, in order to clarify the confusion about medical devices and custom-made products made by dental technicians, and to understand the

proper use of medical devices.