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

  • Flexcera Smile Ultra+ is a next-generation nanoceramic resin for 3D printing a wide range of permanent and temporary dental restorations, including teeth for dentures, crowns, inlays, onlays, bridges, veneers, as well as full, monolithic, and partial dentures
  • Users of Desktop Health, EnvisionTEC, and Carbon 3D printers will be able to print Flexcera Smile Ultra+ on specified DLP printing systems
  • Desktop Health is launching a “Smile, Europe” campaign to educate the dental community about the benefits of Flexcera resins, such as same-day digital workflows and durable and customizable digital designs that are easy to modify and reproduce

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)

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

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

About Desktop Metal

Desktop Metal (NYSE:DM) is driving Additive Manufacturing 2.0, a new era of on-demand, digital mass production of industrial, medical, and consumer products. Our innovative 3D printers, materials, and software deliver the speed, cost, and part quality required for this transformation. We’re the original inventors and world leaders of the 3D printing methods we believe will empower this shift, binder jetting and digital light processing. Today, our systems print metal, polymer, sand and other ceramics, as well as foam and recycled wood. Manufacturers use our technology worldwide to save time and money, reduce waste, increase flexibility, and produce designs that solve the world’s toughest problems and enable once-impossible innovations. Learn more about Desktop Metal and our #TeamDM brands at www.desktopmetal.com.

Forward-looking Statements

This press release contains certain forward-looking statements within the meaning of the federal securities laws. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks, uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this document, including but not limited to, the risks and uncertainties set forth in Desktop Metal, Inc.'s filings with the U.S. Securities and Exchange Commission. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Desktop Metal, Inc. assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise.

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