Desktop Health has secured CE mark approval for its Flexcera resin, which is designed for use in 3D fabrication of dental prosthetics.
The approval allows the company to launch the Flexcera resins for dental professionals within the European Union (EU), as well as other CE Mark geographies.
Flexcera Base and Flexcera Smile are the company’s first formulated and enhanced digital dental solutions.
Last month, the company secured 510(k) clearance from the US Food and Drug Administration for its Flexcera Base.
Desktop Health has developed the Flexcera resin by combining the strength of ceramic with long chain chemistry to maintain optimal denture properties.
Dental providers will be able to print up to eight customised Flexcera dentures within two hours, when the new resin is used exclusively with EnvisionTEC 3D printers .
Flexcera resin, which provides high fracture resistance, is three times more resistant to fracture than select competitive resins, said the company.
The new resin is also moisture resistant, thereby helping to prevent staining or discolouration.
Desktop Health president and CEO Michael Jafar said: “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.
“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 company is planning to commercially introduce the Flexcera resin in Europe in late summer this year. It also intends to launch the new resin in the US and Canada by the end of June.
