181 0 Kommentare Desktop Health Announces that Flexcera Smile Ultra+ is now Available in Europe, Following Recent Class IIa MDR Certification by the European Union

Desktop Health, the trusted health care brand of Desktop Metal (NYSE:DM), announced that its popular Flexcera Smile Ultra+ dental resin, for 3D printing permanent and temporary restorations, is now available for purchase in Europe following its successful certification as a Class IIa medical device under the European Union Medical Device Regulation (MDR).

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20231004075864/en/

Desktop Health's Flexcera Smile Ultra+ dental resin for 3D printing permanent and temporary restorations is now available for purchase in Europe following its successful certification as a Class IIa medical device under the European Union Medical Device Regulation (MDR). (Photo: Business Wire)

Flexcera Smile Ultra+ delivers exceptional strength, life-like aesthetics, and the long-term performance expected from a permanent restoration material. Already an FDA 510(k) Class II cleared material, Flexcera Smile Ultra+ has been commercially available in the United States since February 2022. The EU MDR certification will expand access to the innovative material to more dental labs and clinicians.

“Flexcera Smile Ultra+ has been a breakthrough 3D printing resin for the dental community because of its life-like appearance and exceptional performance,” said Lou Azzara, President of Desktop Health. “Worldwide, the dental industry is going digital — moving to intraoral scanners and digital manufacturing techniques that are giving patients reliable, custom solutions fast, including same-day production and delivery for many applications. Our premium Flexcera material has become a preferred solution for clinicians and patients in this environment, and we’re delighted to finally offer it to our European labs, clinicians, and patients.”

Users of Desktop Health, EnvisionTEC, and Carbon brand DLP 3D printers can purchase Flexcera Smile Ultra+ – starting today – in tooth shades A1, A2, A3, A3.5, B1, and Bleach, through authorized dealers.

To learn more about Flexcera Smile Ultra+ and the Flexcera family of resins, visit TeamDM.com/Flexcera.

About Desktop Health

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Desktop Health, a healthcare brand within the Desktop Metal portfolio, delivers trusted additive manufacturing and material technologies that improve patient lives. For 20+ years, Desktop Health’s high-accuracy 3D printers and premium biocompatible materials have produced regulatory-approved dental, medical, and biofabrication solutions. For more on Desktop Health, visit www.desktophealth.com

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