World’s first digital implant receives European CE mark certification
HÜNENBERG, Switzerland: TRI Dental Implants recently announced that it has obtained CE mark certification, enabling it to market its digital implant, matrix, in Europe.
Matrix is the first approved dental implant specifically developed for digital manufacturing technologies such as CAD/CAM or 3D printing. By means of this new concept, prostheses can be directly planned on the implant without the use of an abutment.
Matrix was first introduced at the International Dental Show in 2019 after it had been extensively verified and validated in preclinical trials. These trials included strength tests, which had up to five million cycles, for all relevant indications and materials as well as detailed clinical evaluations. Currently, several in vitrostudies are being conducted in collaboration with the University of Zurich in Switzerland and Ludwig-Maximilians-Universität München in Germany.
The aim of TRI Dental Implants was to develop a product that ensured unlimited design flexibility. Hence, several kinds of dental restorations―including individual screw-retained, fully anatomical CAD/CAM restorations and multi-part bars and bridges―can be planned and placed directly on the implant. TRI Dental Implants also reported that there are no restrictions in terms of angulation and indication in the use of the implant, no need for cementation, and there is the possibility of planning soft-tissue management digitally.
As production in the laboratory will take place 100% digitally—without gluing and cementing—the matrix implant system renders the conventional digital workflow more efficient. In addition, the fully digital and thus significantly faster production of prostheses will allow practitioners to treat patients in just one session and thereby reduce the number of appointments.
“The CE mark for the world’s first digital implant is an important achievement and a major milestone for TRI Dental Implants. The certification enables the company to market the digital implant in the EU member states from now on,” said Dr Stefan Hund, CEO of TRI Dental Implants.
After having obtained the certification, TRI Dental Implants is now planning to conduct various long-term studies at scientific institutes such as the University of Zurich. In addition, across Europe, a team of experts will be treating the first patients to receive the implants.
According to TRI Dental Implants, approvals for the US and Japanese markets are pending and expected for 2021. The price of the implant system will be communicated at the global market launch in summer 2021.
Further information about matrix is available at www.tri.swiss.