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Braces On Demand and Formlabs Announce FDA Clearance of Innovative 3D Printed Orthodontic System

With this FDA approval, the ground-breaking direct-bonded 3D printed orthodontic system will enable clinicians to manufacture brackets in-office, saving valuable time and money.

March. 22, 2021
Braces On Demand and Formlabs Announce FDA Clearance of Innovative 3D Printed Orthodontic System

With this FDA approval, the ground-breaking direct-bonded 3D printed orthodontic system will enable clinicians to manufacture brackets in-office, saving valuable time and money.

[Hicksville, NY] – March 22, 2021 - Braces On Demand, a technology start-up in the orthodontic industry, and Formlabs, a leading 3D printing company, today announced U.S. Food and Drug Administration (FDA) 510(K) clearance of the Braces On Demand Orthodontic System. This innovative direct-bonded, 3D printed orthodontic system utilizes patent-pending technology enabling clinicians to become their own manufacturer.

The Braces On Demand system seamlessly connects with Formlabs’ Form 3B printer, the company’s flagship dental 3D printer, and enables the clinician to print aesthetic braces and appliances on-demand, saving the cost associated with traditional brackets. The Braces On Demand web application enables clinicians to reduce inventory while also providing unprecedented prescription customization, with over 8 million unique prescription variations. Braces On Demand employs Formlabs’ Denture Teeth Resin as the base material to use along with the Form 3B, Form Wash, and Form Cure for simple and powerful in-office manufacturing. No scanner, thermoforming machine, trimming, or packaging is required, further simplifying this novel in-house 3D printing workflow.

“Clinicians today are faced with a multitude of challenges, including the rising cost of appliances and increased competition from direct-to-consumer aligner companies. At the same time, in-office 3D printing is empowering clinicians to combat these challenges by bringing manufacturing in-office to cut costs and save time,” said Colin Corey, Braces On Demand CEO. “Braces On Demand is pleased to have received 510(K) clearance from the FDA, which will allow clinicians to 3D print brackets and appliances with our easy-to-use application.”

Sam Wainwright, Dental Products Manager of Formlabs, said, “Integrating 3D printing into the orthodontic workflow not only saves on valuable resources, but also empowers clinicians to provide patients with a more personalized experience. Formlabs’ precise 3D printers, fully validated biocompatible resins, and Dashboard with remote printing, coupled with the comprehensive bracket system and intuitive web application from Braces On Demand, enables clinicians to offer patients a more customized experience, all in-office.”

With the 510(K) clearance from the US Food and Drug Administration, Braces On Demand will begin accepting orders from Early Access Pass users beginning March 23rd. To sign up for an Early Access Pass, please visit bracesondemand.com to schedule a demo.

About Formlabs Dental

Formlabs is expanding access to digital fabrication, so anyone can make anything. The leading 3D printing company introduced its new dental business unit in November 2019 to uniquely meet the needs of dental labs and practices of all sizes. Formlabs Dental is made up of a team of dental professionals dedicated to providing the best 3D printing solutions in the industry. Formlabs has touched the lives of hundreds of thousands of patients, having printed 13 million dental parts on the Form 2, and expanding this impact even further with the recent additions of its dental-focused hardware devices, the Form 3B and Form 3BL. In addition to its hardware products, Formlabs has over 50 materials scientists and a robust offering of dental materials that are available to be used on the Form 3B and Form 3BL printer.

About Braces On Demand

Braces On Demand is an orthodontic technology start-up founded in 2019.  Braces On Demand was founded with the purpose of creating a web application to 3D print direct bonded orthodontic appliances in-office.  Braces On Demand was founded by Colin Corey, Ammar Syed, and Dr. Tom Shannon with engineering, dental laboratory, and clinical backgrounds respectively.  Braces On Demand is committed to continuing to push innovation in the 3D printing orthodontic industry.

Formlabs Media Contact
Chelsea Higgins

press@formlabs.com

Braces On Demand Media Contact

press@bracesondemand.com

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