Desktop Health, recently launched by Desktop Metal, Inc. and committed to developing 3D printing and biofabrication solutions for personalized medicine, announced Conformité Européenne (CE) Mark certification for its Flexcera resin, a proprietary technology for use in 3D fabrication of high-quality dental prosthetics.
Flexcera resins meet the requirements of the European Medical Devices Directive, paving the way for Desktop Health to launch Flexcera resins to dental professionals within the European Union (EU) and other CE Mark geographies. Flexcera Base, which recently received U.S. Food and Drug Administration (FDA) 510(k) clearance, and Flexcera Smile are Desktop Health’s first formulated and optimized digital dental materials.
The need for dental prosthetics is on the rise, with the global dentures market estimated to reach $3.8 billion USD by 2027. The European dentures market is a $878 million market1, driven by the advancement of technology which addresses limitation of current 3D printed dental prosthetics in both brittleness and aesthetics.
Flexcera resin was developed with the strength of ceramic coupled with long chain chemistry to ensure optimal denture properties. When used exclusively with EnvisionTEC 3D printers, dental providers can print up to eight custom Flexcera dentures in less than two hours.
Flexcera resin offers:
- High fracture resistance, three times more resistant to fracture than select competitive resins;
- Moisture resistance to prevent staining or discoloration, two times more resistant than a leading competitive formulation; and
- An overall natural aesthetic that offers lifelike tooth translucency and a natural-looking smile.
Flexcera resin is expected to launch commercially in Europe in late summer 2021 and in the U.S. and Canada by the end of June.