Desktop Health received CE Mark Certification and releases Flexcera Next Generation 3D Printed Dentures

Dentures_made_with_Flexcera | French: Prothèses dentaires fabriquées avec du Flexcera -Image: Desktop Helath

With the goal of redefining patient-specific healthcare in the dental, orthodontic and otolaryngology fields, Desktop Metal launched a new business line three months ago. Named Desktop HealthTM and led by President & CEO Michael Mazen Jafar, the new line benefits from the combination of additive manufacturing technologies, that result from the acquisition of EnvisionTEC and Adaptive3D.  Those technologies include bioprinting, high-speed metal binder jetting, and the use of advanced biocompatible materials across polymers, ceramics and metals to develop advanced healthcare applications.

Today the world manufactures more than $85 billion in medical and dental implants each year,” said Ric Fulop, CEO and co-founder of Desktop Metal. “We think a large percentage of these parts could be printed and made patient-specific before the end of the decade, making this market a key opportunity for Desktop Metal.”

Two months after the announcement, this new subsidiary 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 solution is very timely as the need for dental prosthetics is on the rise, with the global dentures market estimated to reach $3.8 billion USD by 2027. In the U.S. alone, more than 36 million are edentulous, meaning they have no natural teeth, with 90 percent of those wearing dentures.

From a technological standpoint, it should be noted that Flexcera resin 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.

Key characteristics of the material include therefore 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; as well as an overall natural aesthetic that offers lifelike tooth translucency and a natural-looking smile.

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.”

Most importantly, as the company plans to bring its solution outside the American borders, and address European needs, it has also received (Conformité Européenne) CE Mark certification for its FlexceraTM resin. This means that the materials meet the requirements of the European Medical Devices Directive, enabling Desktop Health to provide the Flexcera resins to dental professionals within the European Union (EU) and other CE Mark geographies.

“We are very pleased to report CE Mark certification for Flexcera, launching our global expansion to meet the needs of dental professionals and their patients,” 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.”

Remember, you can post job opportunities in the AM Industry on 3D ADEPT Media free of charge or look for a job via our job board. Make sure to follow us on our social networks and subscribe to our weekly newsletter : FacebookTwitterLinkedIn & Instagram ! If you want to be featured in the next issue of our digital magazine or if you hear a story that needs to be heard, make sure to send it to contact@3dadept.com