Desktop Health has announced CE certification for its Flexcera resin, a proprietary technology for the 3D printing of dental prosthetics.
The CE Mark confirms that Flexcera resins meet the requirements of the European Medical Devices Directive, allowing Desktop Health to expand into the European Union and other CE Mark geographies. It follows last month’s announcement that Flexcera Base received U.S. Food and Drug Administration 510(k) clearance.
Desktop Health’s Flexcera resin is made up of ceramic coupled with long chain chemistry and is said to enable ‘optimal denture properties.’ With EnvisionTEC 3D printing systems, users can print up to eight customised Flexcera dentures within two hours. Dentures printed with Flexcera resins are said to boast high fracture resistance, moisture resistance to prevent staining or discolouration, and a natural aesthetic that offers lifelike tooth translucency.
Flexcera is expected to launch commercially in Europe in late summer 2021 and in the US and Canada by the end of June.
“We are very pleased to report CE Mark certification for Flexcera, launching our global expansion to meet the needs of dental professionals and their patients,” commented Michael Jafar, President & CEO of Desktop Health. “The introduction of Flexcera marks the inception of a remarkable new era in dentistry, combining advanced Flexcera science with 3D printing technology to deliver superior strength, aesthetics and function for patients.”
“The ability to deliver beautiful, high-quality, printable dental prosthetics is a powerful new capability made possible by Flexcera and Desktop Health,” added Prof. Patrik Zachrisson, co-founder and Vice President of the International Digital Dental Academy and a Partner Dentists at Digital Smile Studio in the UK. “Until now, the production of dentures has been limited to milling methods which are time-consuming, or 3D printing methods which have been brittle. For the first time, with Flexcera, we now have a complete digital denture solution that delivers on the four cornerstones of what should be expected from 3D printing: strength, high aesthetics, accuracy and speed.”
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