Desktop Health, the health division of 3D printer manufacturer Desktop Metal, announced that its popular Flexcera Smile Ultra+ dental resin for 3D printing permanent and temporary restorations is now available in Europe following successful certification as a Class IIa medical device under the European Union Medical Device Regulation (MDR).
Developed for 3D printing of permanent and temporary restorations, this material has already enjoyed popularity in the U.S. after its launch there in February 2022, accompanied by FDA 510(k) Class II clearance.
Flexcera Smile Ultra+ boasts exceptional strength, lifelike esthetics and the long-term performance expected from a permanent restorative material.
“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.”
The global dental industry is currently experiencing a digital transformation. It is shifting towards intraoral scanners and digital manufacturing techniques that offer patients fast, reliable and customized solutions, 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 are pleased to finally offer it to our European labs, clinicians and patients,” Azzara added.
Users of Desktop Health, EnvisionTEC and Carbon 3D printers based on digital light processing (DLP) technology can now purchase Flexcera Smile Ultra+ in A1, A2, A3, A3.5, B1 and Bleach tooth colors through authorized distributors.
EU MDR certification provides access to this innovative material for more dental laboratories and clinicians in Europe, expanding opportunities in the dental restorative industry. It remains to be seen how Flexcera Smile Ultra+ will establish itself in the European market and to what extent it will help to further advance 3D printing in the dental sector.
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