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Formlabs’ Premium Teeth Resin receives FDA 510(k) clearance

Dental professionals in the US can now use the material to 3D print temporary single units and up to seven-unit temporary bridges

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Formlabs Dental’s 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 US 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. 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.

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, President of Healthcare at Formlabs. “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.”

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