Formlabs’ Premium Teeth Resin Garners FDA 510(k) Clearance for Temporary Crowns and Bridges | Image credit: © Formlabs Dental
Formlabs Dental’s Premium Teeth Resin, unveiled earlier this year at the 2024 Consumer Electronics Show (CES), received FDA 510(k) medical device clearance for 3D printing of temporary single-unit crowns, inlays, inlays and veneers and more. on seven-unit temporary bridges, the company announced Tuesday.
This license allows US Formlabs Dental users to produce a variety of dental devices, all with 1 hardware solution. Those apps were previously cleared in the EU, the company says.
Premium Teeth Resin is a biocompatible nanoceramic material with improved aesthetics that mimics the translucency and pallor of natural teeth. They are specifically designed for each patient’s intraoral anatomy and components manufactured with Premium Teeth Resin are designed to have optimal aesthetics, improved intraoral mechanical properties, accuracy and simple workflow to provide affordable patient-specific dental care for different needs patients.
Since its launch in January, clinicians have turned to Premium Teeth Resin for 3D printing of denture teeth and full implant-supported temporary restorations (All-on-X devices), says Formlabs Dental. Available for the company’s Form 3B+, Form 3BL and Form 4B 3D printers, the latest indication of dental resin for temporary restorations allows dental professionals to expand their applications to a range of patient-specific treatments with simplified workflows, realistic aesthetics and validated longevity for optimal clinical performance.
“Recently, we had a patient with a dental emergency. It was Friday afternoon, he had lost an onlay we had placed years ago and was leaving for vacation early the next morning. Using Premium Teeth Resin and a Formlabs Form 4B 3D printer, we were able to quickly print a robust temporary restoration in just 16 minutes,” says Christopher Baer, DMD, Baer Dental, in a press release. “This rapid recovery would not have been possible without the speed of Form 4B and the effectiveness of Premium Teeth Resin.”
The dental 3D printing company reports that over 15 million dental parts have been printed with Formlabs dental 3D printers. Affordable and accessible 3D printing workflows and specialized materials are said to lower cost and labor barriers to dental 3D printing compared to traditional methods, sparking a surge in digital dentistry.
“At Formlabs, our goal is to develop the tools and materials that enable dentists to create patient-specific treatment plans for a range of dental applications,” adds Guillaume Bailliard, Formlabs President, Healthcare. “FDA 510(k) Clearance of Premium Teeth Resin for Temporary Crowns and Bridges furthers our mission by expanding the capabilities of our resins to simplify workflows for dental professionals and deliver the best outcomes for patients.”
When Premium Teeth Resin was introduced at CES, the company also introduced an innovative resin pumping system, a plug-and-play replacement for standard one-liter cartridges. The system allows dental labs to reduce cost per part, and switching to a larger resin supply also provides an 86% reduction in packaging waste, according to Formlabs.
In addition to its hardware products, Formlabs has a strong offering of dental materials available for use on Form 3B+, Form 3BL and Form 4B 3D printers.
