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Stratasys has its first FDA-cleared medical device

February 7, 2023 By Chris Newmarker

Stratasys marketing image showing 3D-printed dentures printed with the new TrueDent resin

3D-printed dentures printed with the new TrueDent resin [Image courtesy of Stratasys]

Stratasys (NASDAQ: SSYS) today introduced its TrueDent resin for making 3D-printed dentures.

TrueDent is the first FDA-cleared medical device for the company, which is based in Eden Prairie, Minnesota and Rehovot, Isreal. The Class II dental resin is made specifically for the fabrication of dental appliances, including removable dentures.

The company had the resin developed for printing exclusively with the Stratasys J5 DentaJet 3D printer and GrabCAD Print software platform.

According to Stratasys, the offering will enable dental labs to scale manufacturing by simplifying workflow and reducing processing time for dentures, while achieving a personalized, highly aesthetic dental appliance.

Stratasys sees a multibillion-dollar opportunity to take the stress out of making dentures

Stratasys says advantages include:

  • Potential to reduce chair time for office visits, measurements, fittings and adjustments;
  • High-fidelity match between scan, design and fit;
  • Repeatable, scalable digital solutions that can provide consistent production of accurate, well-fitting dentures;
  • And increased efficiency through streamlined workflow with less time between scan and delivery.

“Until now, printed dentures and appliances had to be designed and manufactured in multiple parts and bonded together,” Frank Acosta, owner of AA Dental Design, said in a Stratasys news release. “The TrueDent solution, utilizing Stratasys’ systems and software takes a lot of that stress out.”

Acosta said TrueDent simplifies the process, lowers costs, and allows for faster production of dentures and temporaries. “We can now expand our prosthetic service printing multi-colored personalized appliance at scale.”

Stratasys estimates that the global dentures market is $5.5 billion.

“This new solution will be transformative for the dental industry, and we believe it will help our customers significantly reduce the time and cost of producing dentures and temporaries,” said Ronen Lebi, VP of Dental at Stratasys. “Stratasys continues to push the boundaries of digital dentistry leveraging our portfolio of advanced 3D printing technologies, including hardware, resins and software to deliver disruptive solutions that make a difference.”

About The Author

Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at cnewmarker@wtwhmedia.com.

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