Formlabs Advances its Dental 3D Printing Capabilities with FDA Approval and Open Material Mode for Form 4

As the company continues to grow in the dental 3D printing segment, Formlabs has announced that its Premium Teeth Resin has received FDA 510(k) Medical Device Clearance. The material was already cleared in the EU, so this approval now allows dental professionals across the United States to use this material to 3D print temporary crowns, bridges, inlays, onlays, and veneers, enabling a broader range of dental applications with a single material solution.

The Premium Teeth Resin is a nano-ceramic filled biocompatible material designed to mimic the natural translucency and opalescence of real teeth. This material allows dental professionals to produce aesthetic and patient-specific dental appliances with the accuracy and intraoral mechanical properties possible with Formlabs technology. Available for the Form 3B+, Form 3BL, and Form 4B 3D printers, the resin is said to enable a simple workflow, making it potentially a more affordable and efficient option for dental practices.

Since its launch, Premium Teeth Resin has been used to create denture teeth and temporary full-arch implant-supported restorations. The new FDA clearance for temporary restorations now allows dentists to expand their offerings significantly. This material supports a range of treatments with life-like aesthetics and validated longevity, ensuring clinical performance.

Dr. Christopher Baer, DMD of Baer Dental, said of the material, “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. This quick turnaround wouldn’t have been possible without the speed of Form 4B and the effectiveness of Premium Teeth Resin.”

Guillaume Bailliard, President of Healthcare at Formlabs, stated, “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.”

New Developments in 3D Printing Software: PreForm 3.38

In parallel with its advances in dental materials, Formlabs also announced significant updates to its software suite, aimed at enhancing the capabilities of its Form 4 3D printers. A notable feature requested by users, angle snapping, has been added to make part rotation faster and more precise. This allows users to rotate parts in 15° increments, simplifying the process of adjusting part orientation for optimal printing results. More importantly, the latest PreForm 3.38 release includes the introduction of Open Material Mode (OMM) for Form 4 Series printers, allowing expert users to experiment with custom resins. This feature provides unprecedented opportunities for research and innovation in 3D printing materials. The OMM enables users to print with any 405 nm photopolymer resin, thus unlocking new possibilities for material innovation and application development.

With this update, Formlabs becomes the latest in the market to introduce an open materials feature, following others like Stratasys and 3D Systems. This will not only allow researchers and material developers to optimize and test their resins on Formlabs machines, but also make the company more competitive against lower cost machines that already have open material functionality.

The Larger Dental 3D Printing Market

The FDA approval for Formlabs’ Premium Teeth Resin comes at a critical time for the rapidly growing dental 3D printing market, which is projected to reach approximately $3.8 billion by 2027, up from $1.1 billion in 2020, according to the “3D Printing In Dentistry 2023” report from Additive Manufacturing Research. This growth is driven by increased digitization within dental practices and the demand for same-day dental solutions. The market is shifting from aligners to restorative applications like crowns and dentures, with in-office printing gaining traction due to its ability to deliver quick, customized solutions. Formlabs capitalizes on this trend with its Premium Teeth Resin, offering a biocompatible material that mimics the natural aesthetics of teeth, aligning with the market’s demand for high-quality, patient-specific dental applications.

Formlabs faces stiff competition from companies like SprintRay, LuxCreo, Carbon, Desktop Health, 3D Systems, and Stratasys, all of which are expanding their FDA-approved material offerings and advanced printing technologies. SprintRay and LuxCreo focus on high-speed in-office solutions and rapid curing technologies, respectively, making them formidable competitors in restorative dentistry. However, Formlabs distinguishes itself with the introduction of Open Material Mode, allowing dental professionals to experiment with custom resins . This feature positions Formlabs as a versatile and adaptive player in the market, catering to the growing demand for personalized dental solutions. By leveraging its technological advancements and strategic focus on quality and integration, Formlabs is well-positioned to capture a significant share of the expanding dental 3D printing market—perhaps in time for an IPO?