Formlabs’ Premium Teeth Resin Receives FDA 510(k) Clearance for Temporary Crowns and Bridges Expanding Its Dental 3D Printing Application
With FDA 510(k) Medical Device Clearance, dental professionals in the U.S. can now use Premium Teeth Resin to 3D print temporary single units and up to seven-unit temporary bridges. The application was previously cleared in the EU.
Somerville, MA, 6 Aug 2024 – Formlabs Dental, a leading dental 3D printing company, today announced its Premium Teeth Resin 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, enabling U.S. Formlabs Dental users to produce a variety of dental appliances, all with one material solution. These applications were previously cleared in the EU.
Premium Teeth Resin is a nano-ceramic filled biocompatible material with enhanced aesthetics that mimics the translucency and opalescence of natural teeth. Custom-designed for each patient’s intraoral anatomy, parts made with Premium Teeth Resin feature industry-leading aesthetics, optimal intraoral mechanical properties, accuracy, and a simple workflow to enable affordable, patient-specific dental care for diverse patient needs.
Since its launch in January, dentists have relied on Premium Teeth Resin to 3D print denture teeth and temporary full-arch implant-supported restorations (All-on-X appliances). Available for Form 3B+, Form 3BL, and Form 4B 3D printers, Premium 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 aesthetics, and validated longevity to guarantee 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. This quick turnaround wouldn't have been possible without the speed of Form 4B and the effectiveness of Premium Teeth Resin,” said Dr. Christopher Baer, DMD, Baer Dental.
Formlabs leads the dental 3D printing industry: over 15 million dental parts have been printed with Formlabs Dental 3D printers. Affordable and accessible 3D printing workflows and specialty materials 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,” said 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.”
About Formlabs Dental
Formlabs builds the tools that make it possible for anyone to bring their ideas to life. The leading 3D printing company’s dental business unit, Formlabs Dental, is made up of a team of dental professionals dedicated to providing the best 3D printing solutions in the industry. Uniquely meeting the needs of dental labs and practices of all sizes, Formlabs Dental has touched the lives of hundreds of thousands of patients, with 15 million dental parts printed on Formlabs printers, and expanding this impact even further with the recent additions of its dental-focused hardware, including the new Form 4B. 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.