A company that grew out of a laboratory at the Department of Dentistry, Enlighten Materials has been certified by the U.S. FDA and Taiwan TFDA for Class II 3D-printed dental composite resin medical materials

2023-03-20

The laboratory team led by Distinguished Professor Lee Shyh-Yuan and Professor Lin Yuan-Min from the Department of Dentistry has developed four different types of composite resin medical materials: temporary denture resin, full denture base material, individual dental tray resin, and dental implant guide plate resin. In order to meet the expectation of the MOST, Enlighten Materials has succeeded in having 4 materials pass certification by the FDA in the United States, TFDA in Taiwan, Anvisa in Brazil, and respective agencies in other countries. In addition, the implant guide plate resin has additionally obtained EU CE certification. Currently, the two Class II medical material resins temporary denture resin (K191590) and full denture base material (K191591) have passed 510K reviews by the US FDA in May and August 2020, respectively. These are also the third and fourth applications for temporary denture resin and full denture base material resin to be approved by the FDA globally. The two also gained TFDA certification at the end of January 2021, which are the only Class II medical resin materials in the world to have passed TFDA. Enlighten Materials is one of the few local companies capable of producing composite resin dental materials. As a result, the team also received the 2020 National Innovation Award, the 2021 MOHW Pharmaceutical Science and Technology Research and Development Award (Silver Award for Medical Devices), and the MOEA SME Outstanding Enterprise-Business Startup Award.

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