Desktop Health, recently launched by Desktop Metal, Inc. (NYSE: DM), which develops 3D printing and biotechnology solutions for personalized medicine, today announced the Conformité Européenne (CE) Mark certification for its Flexcera.TM resin, a patented technology for use in the 3D fabrication of high quality dentures. The CE mark confirms that Flexcera resins comply with the European Medical Device Directive, paving the way for Desktop Health to release Flexcera resins for dentists in the European Union (EU) and other CE-marked regions. Flexcera Base, recently FDA 510 (k), and Flexcera Smile are the first Desktop Health digital dental solutions designed and optimized.
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Desktop Health announces CE Mark certification and the international launch of Flexcera, a proprietary resin for use in the 3D manufacturing of high quality dentures. The introduction of Flexcera Base and Flexcera Smile heralds a new era in dentistry, combining cutting edge science with 3D printing technology to provide patients with superior durability, aesthetics and functionality. (Photo: Business Wire)
“We are thrilled to announce the CE Mark for Flexcera, launching our global expansion to meet the needs of dentists and their patients,” said Michael Jafar, President and CEO of Desktop Health. “The introduction of Flexcera heralds a remarkable new era in dentistry, combining Flexcera’s cutting edge science with 3D printing technology to provide patients with superior durability, esthetics and functionality.”
The demand for dentures is growing and the global denture market is estimated to reach US $ 3.8 billion by 2027. The European denture market is US $ 878 million.onedriven by the development of technologies that remove the limitations of modern 3D printed dentures, both in terms of fragility and aesthetics.
The Science of Teeth Printing
Flexcera resin has been developed based on the strength of ceramics combined with a long chain chemistry to provide optimal denture properties. When used exclusively with EnvisionTEC ™ 3D printers, dental service providers can print up to eight custom-made Flexcera dentures in less than two hours, ensuring high quality dentures on the same day.
For the first time in dental prosthetics, Flexcera resin offers:
High shatter resistance, three times more shatter resistant than some competing resins;
Moisture resistance to prevent staining or discoloration, twice as resistant as leading competing formulations; as well as
Overall natural aesthetics for realistic tooth transparency and a natural smile.
“The ability to create beautiful, high-quality, printable dentures is a powerful new opportunity made possible by Flexcera and Desktop Health,” said Professor Patrick Zachrisson, Co-Founder and Vice President of the International Digital Dental Academy and Dentist Partner. at Digital Smile Studio in the UK. “Until now, the production of dentures has been limited to milling methods that were time consuming or 3D printing methods that were fragile. For the first time with Flexcera, we now have a complete digital denture solution that delivers the four cornerstones of what to expect from 3D printing: strength, aesthetics, precision and speed. ”
Flexcera resin is expected to go on sale in Europe in late summer 2021 and in the US and Canada by the end of June. Healthcare providers who wish to keep abreast of product availability or to place a pre-order can register at www.flexcera.com.
About Flexcera resins
Flexcera’s patented resins produce beautiful, functional dentures with a ceramic-like strength. Flexcera Smile is an FDA Class 1 medical device and is CE marked for realistic dentures and Flexcera Base is an FDA 510 (k) Class 2 approved medical device with CE marking for premium denture bases. Both are designed exclusively for use with EnvisionTEC 3D printers. For more information visit www.flexcera.com.
About the health of the desktop
Desktop Health, based in Newport Beach, California, develops additive manufacturing solutions and advanced materials for personalized patient care. The company was founded in March 2021 as a medical business under Desktop Metal, Inc. and is vertically integrated for the development, production and commercialization of applications for various medical specialties. Desktop Health is rapidly focusing on developing applications and unlocking opportunities to leverage its bioprinting capabilities in healthcare. For more information on Desktop Health visit www.desktophealth.com.
About Desktop Metal, Inc.
Desktop Metal, Inc., based in Burlington, Massachusetts, is accelerating manufacturing transformation with a broad portfolio of 3D printing solutions, from rapid prototyping to mass production. Founded in 2015 by leaders in advanced manufacturing, metallurgy and robotics, the company addresses the challenges of speed, cost and quality to make additive manufacturing an essential tool for engineers and manufacturers around the world. Desktop Metal has been selected by the World Economic Forum as one of the 30 most promising technology pioneers in the world and included in the MIT Technology Review’s 50 smartest companies. For more information visit www.desktopmetal.com.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Stock Exchange Act of 1934, as amended. Forward-looking statements typically refer to Desktop Health’s potential and future performance, including its strategic focus, the development of new healthcare applications, the introduction or success of new technologies and applications, and expected results. Forward-looking statements are forecasts, forecasts and other statements about future events based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this document, including but not limited to: (i) the ability to meet business plans, forecasts and other expectations, and identify and implement additional opportunities; (ii) regulatory requirements that will apply to Desktop Health technology, products, materials and applications, including by the FDA and similar agencies in other countries; (iii) risks associated with products manufactured by Desktop Health, including product liability or warranty claims; and (iv) other risks and uncertainties set out in the Risk Factors and Forward-Looking Statements section of the Company’s 10-K / A Annual Report filed with the US Securities and Exchange Commission. (“SEC”) April 30, 2021, and other Company documents with the SEC. These documents identify and eliminate other important risks and uncertainties that could cause actual events and results to differ materially from those contained in forward-looking statements. … Forward-looking statements included in this press release are valid only as of the date they are made. Readers are advised not to place undue reliance on forward-looking statements and Desktop Metal assumes no obligation and does not intend to update or revise them. Forward-looking statements, whether as a result of new information, future events or otherwise, Desktop Metal makes no guarantee that it will meet its expectations.
1 Fortune Business Insights, Denture Market Size, Industry Share and Analysis, July 2020.
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