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Research Highlights, Digital Manufacturing of Medical Devices Finally Reaches Society

Life Science and Biotechnology
Digital Manufacturing of Medical Devices Finally Reaches Society
OKAZAKI Yoshimitsu
Health Research Institute

The first time in Japan! Medical device artificial teeth made using a 3D printer

Pharmaceutical regulatory approval for a cobalt-chromium alloy powder as a medical device has been obtained for the first time in Japan, enabling manufacture of artificial teeth using 3D printing technology.

Figure: Production of artificial teeth using 3D printing technology
Production of artificial teeth using 3D printing technology

Supporting the future of manufacturing in dental industry

It is a challenge to manufacture artificial teeth with complex three-dimensional structures using conventional dental casting technology. However, manufacture of partial dentures by a cutting process has a long processing time and poor material yield. The number of persons employed as dental technicians is decreasing and their age is also increasing, so the future of the industry is not bright. Therefore, to increase the attractiveness of manufacturing in dental industry, this research aims to achieve practical application of artificial teeth made with 3D additive manufacturing technology using 3D printing that enables cost and process reduction by employing latest technology. This 3D additive manufacturing technology obtains the data of oral cavity and designs the ideal artificial teeth for the patient. Additive manufacturing is performed based on that design data, the surface is finished to complete the artificial teeth, and the artificial teeth are then used in dental treatment. This enables digital dental manufacturing.

Photo: Background

AIST played a central role in obtaining pharmaceutical regulatory approval

AIST functioned as the secretariat to create and publish "Guidelines for Development of Dental Prosthetic Devices Using 3D Additive Manufacturing Technology" with the aim of promoting the development of dental prostheses. Based on the guidelines, IDS Co., Ltd. applied for pharmaceutical regulatory approval for manufacturing and marketing of the cobalt-chromium alloy powder. AIST prepared the conditions for practical application by investigating the microstructure of the additive manufacturing material and clarifying the effects of particle size and layering direction on durability. These reduced the susceptibility to breakage and enabled to manufacture the ideal artificial teeth for the patient in a short time. By automatic additive manufacturing at night and then finishing the artificial teeth the next morning, the manufacturing time can be shortened. This technology realized a tensile strength and elongation at break on the same level as that of forged materials, which could not be achieved by conventional dental casting technology. In addition, the fatigue strength after repeated loading of up to 10 million times was twice that of forged materials. A series of research showed that repeated melting and rapid solidification of the powder result in a metal structure with finely dispersed precipitates, which realizes high strength, high ductility, high durability, and high corrosion resistance.

Photo: New results

Coverage by the health insurance system of Japan and allergy countermeasures.... Further address issues to make this technology even more familiar.

AIST will work with related agencies to make the additive manufacturing technology covered by the health insurance system of Japan, and will also work to obtain pharmaceutical regulatory approval that includes domestically produced powders of cobalt-chromium alloy. In addition, artificial teeth that use titanium materials will also be developed in consideration of sensitive allergic patients.

Photo: Okazaki Yoshimitsu

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