Formlabs’ Premium Teeth Resin Garners FDA 510(k) Clearance for Temporary Crowns and Bridges

Formlabs’ Premium Teeth Resin Garners FDA 510(k) Clearance for Temporary Crowns and Bridges | Image Credit: © Formlabs Dental

Formlabs Dental’s Premium Teeth Resin, which was unveiled earlier this year at the 2024 Consumer Electronics Show (CES), has received FDA 510(k) Medical Device Clearance for 3D printing temporary single units of crowns, inlays, onlays, and veneers, and up to seven-unit temporary bridges, the company announced on Tuesday.

This clearance enables U.S. Formlabs Dental users to produce a variety of dental appliances, all with 1 material solution. These applications were previously cleared in the EU, the company states.

Premium Teeth Resin is a nano-ceramic filled biocompatible material with enhanced esthetics that mimics the translucency and opalescence of natural teeth. They are custom-designed for each patient’s intraoral anatomy, and parts made with Premium Teeth Resin are designed to feature optimal esthetics, enhanced intraoral mechanical properties, accuracy, and a simple workflow to enable affordable, patient-specific dental care for diverse patient needs.

Since its launch in January, clinicians have turned to Premium Teeth Resin to 3D print denture teeth and temporary full-arch implant-supported restorations (All-on-X appliances), Formlabs Dental says. Available for the company’s Form 3B+, Form 3BL, and Form 4B 3D printers, the teeth resin’s newest indication of temporary restorations allows dental professionals to expand their applications to a range of patient-specific treatments with simplified workflows, life-like esthetics, and validated longevity for optimal clinical performance.

“Recently, we had a patient with a dental emergency. It was Friday afternoon, he’d lost an onlay we had placed years ago and was leaving on vacation early the next morning. Using Premium Teeth Resin and Formlabs Form 4B 3D printer, we were able to quickly 3D print a robust temporary restoration in just 16 minutes,” Christopher Baer, DMD, Baer Dental, states in a press release. “This quick turnaround wouldn't have been possible without the speed of Form 4B and the effectiveness of Premium Teeth Resin.”

The dental 3D printing company reports over 15 million dental parts have been printed with Formlabs Dental 3D printers. Economical and accessible 3D printing workflows and specialty materials are said to reduce the cost and labor barriers to dental 3D printing compared to traditional methods, sparking a rise 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. “The 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 provide the best outcomes for patients.”

When the Premium Teeth Resin was unveiled at CES, the company also debuted an innovative Resin Pumping System, a plug-and-play replacement for standard one-liter cartridges. The system allows dental labs to reduce their cost-per-part, and the move 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 robust offering of dental materials that are available for use on Form 3B+, Form 3BL, and Form 4B 3D printers.