Formlabs’ Teeth Resin Receives FDA 510(k) Clearance

Formlabs Dental, a dental 3D printing company, announces 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 7-unit temporary bridges, enabling U.S. Formlabs Dental users to produce various dental appliances, with one material solution. These applications were previously cleared in the EU.

Premium Teeth Resin is a nanoceramic-filled biocompatible material with enhanced esthetics that mimics the translucency and opalescence of natural teeth. Custom-designed for each patient’s intraoral anatomy, parts made with Premium Teeth Resin feature esthetics, optimal intraoral mechanical properties, accuracy, and simplified workflow, the company claims.

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. 

“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,” says Dr. Christopher Baer, DMD, Baer Dental.

“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,” says 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.”

Sources: Press materials received from the company and additional information gleaned from the company’s website.

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