Desktop Health Receives Clearance from FDA for Flexcera A Resin for 3D Printed Dentures

Desktop Health Receives Clearance from FDA for Flexcera A Resin for 3D Printed Dentures

Tweet this
“Three years ago, we set out to create a product that addressed the limitations of current 3D printed dental prosthetics – brittleness and poor aesthetics,” said Michael Jafar, President & CEO of Desktop Health. “The introduction of Flexcera marks the inception of a remarkable new era in dentistry, combining advanced Flexcera science with 3D printing technology to deliver superior strength, aesthetics, and function for patients. We are pleased to bring this innovative product to market as it represents our commitment to meet the needs of dental professionals and their patients.”

Desktop Health, recently launched by Desktop Metal, Inc. (NYSE: DM) and committed to developing 3D printing and biofabrication solutions for personalized medicine, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance of FlexceraTM Base, a proprietary resin for use in 3D fabrication of high-quality dental prosthetics. Flexcera Base along with the new FlexceraTM Smile are Desktop Health’s first formulated and optimized digital dental solutions.

The need for dental prosthetics is on the rise, with the global dentures market estimated to reach $3.8 billion USD by 20271. In the U.S. alone, more than 36 million are edentulous, meaning they have no natural teeth, with 90 percent of those wearing dentures2. According to the American Association of Oral and Maxillofacial Surgeons, 69 percent of adults ages 35 to 44 have lost at least one permanent tooth to an accident, gum disease, a failed root canal or tooth decay3.

The Science of Printing Teeth
Flexcera 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 customized Flexcera dentures in less than two hours, delivering on the promise of same-day, high-quality dental prosthetics.

For the first time in dental prosthetics, Flexcera 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.
“Desktop Health has changed my approach to personalized dentistry,” said Dr. Ryan Dunlop, DMD of Full Arch Masters, one of the leading experts in dental implants and digital dentistry. “The Flexcera resin delivers on the four cornerstones of why 3D printing works so well: strength, high aesthetics, accuracy and speed. With Flexcera, I am now able to deliver beautiful, high-quality and same-day dental prosthetics in record time, customized to the patient, while they are in the chair.”

Desktop Health will present the details of this new technology to dental professionals for the first time at the LAB DAY Online Spring meeting on May 12 and May 14, 2021. More Information about the LAB DAY program is available at: https://lmtmag.com/shows/lab-day-online-spring-2021.

Flexcera is expected to launch commercially in the U.S. and Canada by the end of June. Healthcare providers who wish to stay updated on product availability, or place a pre-order, can sign up at www.flexcera.com.

About Flexcera Resins
Flexcera is comprised of proprietary resins for the fabrication of beautiful, functional dentures with ceramic-like strength. Flexcera Smile is an FDA Class 1 Medical Device for the fabrication of lifelike denture teeth and Flexcera Base is an FDA Cleared Class 2 Medical Device for the fabrication of premium denture bases. Both are formulated exclusively for use with EnvisionTEC 3D printers. For more information, visit www.flexcera.com. About Desktop Health
Based in Newport Beach, California, Desktop Health develops additive manufacturing solutions and advanced materials for personalized patient care. Founded in March 2021 as a healthcare business within Desktop Metal, Inc., the business is vertically integrated to develop, manufacture, and commercialize applications across a range of healthcare specialties. Desktop Health is rapidly focused on developing applications and uncovering opportunities to leverage its bio-printing capabilities within healthcare. For more information on Desktop Health, visit www.desktophealth.com.

About Desktop Metal, Inc.
Desktop Metal, Inc., based in Burlington, Massachusetts, is accelerating the transformation of manufacturing with an expansive portfolio of 3D printing solutions, from rapid prototyping to mass production. Founded in 2015 by leaders in advanced manufacturing, metallurgy, and robotics, the company is addressing the unmet challenges of speed, cost, and quality to make additive manufacturing an essential tool for engineers and manufacturers around the world. Desktop Metal was selected as one of the world’s 30 most promising Technology Pioneers by the World Economic Forum and named to MIT Technology Review’s list of 50 Smartest Companies. For more information, visit www.desktopmetal.com. FORWARD LOOKING STATEMENTS
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 Securities Exchange Act of 1934, as amended. Forward-looking statements generally relate to Desktop Health’s potential and future performance, including its strategic focus, development of new healthcare applications, adoption or success of new technologies and applications, and anticipated results. 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 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 implement business plans, forecasts, and other expectations and identify and realize additional opportunities; (ii) the regulatory requirements that will apply to Desktop Health’s technology, products, materials and applications, including by the U.S. Food and Drug Administration and comparable 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 forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward Looking Statements”” in the Annual Report on Form 10-K filed by the Company with the U.S. Securities and Exchange Commission (the “SEC”) on March 15, 2021, and the Company’s other filings with the SEC. 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. The forward-looking statements included in this press release speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Desktop Metal 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. Desktop Metal does not give any assurance that it will achieve its expectations.

The News Highlights

  • Desktop Health Receives Clearance from FDA for Flexcera A Resin for 3D Printed Dentures
  • Check the latest update on Gadgets news
Disclaimer: If you need to edit or update this news from compsmag then kindly contact us Learn more

For Latest News Follow us on Google News


Latest Headlines
  • Show all
  • Trending News
  • Popular By week
Mental Health, Substance Use Treatment Funding in Jeopardy – Connecticut News

Mental Health, Substance Use Treatment Funding in Jeopardy – Connecticut News

“So we have a crisis. And we thought we were close to a solution, but instead of passing a budget that increased funding for all nonprofits, as the ...
Intuit alerts users about compromised TurboTax accounts

Intuit alerts users about compromised TurboTax accounts

In a breach notification letter sent to affected customers earlier this month, the company said that this was not a “systemic data breach of Intuit.” ...
Back 4 Blood Will Be Available on Xbox Game Pass at E3 2021

Back 4 Blood Will Be Available on Xbox Game Pass at E3 2021

A spiritual sequel to Left 4 Dead, developed by Turtle Rock Studios — a studio which hosts many former Left 4 Dead developers — the game is a co-op zombie ...
Social Determinants of Health: Aggregate Precision Investment

Social Determinants of Health: Aggregate Precision Investment

Source: Authors’ illustration. Exhibit 1: Aggregate stakeholder benefit compared to total cost of a SDOH intervention The sobering outcome of this reality is ...
Headphones & Earbuds causing trouble To Youth Hearing

Headphones & Earbuds causing trouble To Youth Hearing

According to Medical Xpress, children and teenagers are listening to music at volumes that are not considered safe, and this could have some serious ...
Unsurprisingly Google  looking to Samsung for its foldable phone display

Release date, pricing, news, leaks, and speculations about the Samsung Galaxy Z Flip 3

It is over a 12 months since we noticed the launch of the Samsung Galaxy Z Flip, although, so it may not be too lengthy earlier than the successor comes. ...
Outworx Group acquires Gold Landscape

Outworx Group acquires Gold Landscape

About Outworx Headquartered in Dallas, TX, Gold is a leading landscape services provider to HOA communities, multi-family properties, commercial properties ...
State Department of Health detects Delta COVID-19 variant in resident who traveled to Nevada

State Department of Health detects Delta COVID-19 variant in resident who traveled to Nevada

The individual developed mild symptoms several days after returning home and tested positive. The department said the person went into isolation and their ...
Cohen Veterans Bioscience presents Voices of Veterans webinar to mark 'Mental Health Action Day' on May 20, 2021 |  national news

Walden University hosts virtual panel on post-COVID youth mental health and support strategies

About Walden University More than 50 years ago, Walden University was founded to support adult learners in achieving their academic goals and making a greater ...
During the Xbox and Bethesda Games Showcase, The Outer Worlds 2 was unveiled

During the Xbox and Bethesda Games Showcase, The Outer Worlds 2 was unveiled

The Outer Worlds 2 has been announced during the Xbox and Bethesda Showcase. Prepare to journey to the edges of the galaxy once more Obsidian Entertainment ...
Show next
Compsmag - Latest News from tech, business and health
Logo