Formlabs Dental, a leading dental 3D printing company, announced that its Premium Teeth Resin has received FDA 510(k) Medical Device Clearance for 3D printing temporary single units of crowns, inlays, onlays, and veneers, as well as up to seven-unit temporary bridges, allowing Formlabs Dental users in the United States to create a wide range of dental appliances using a single material solution. These applications were previously approved in the EU.
The resin was introduced in January and has since been used by dentists to 3D print denture teeth and temporary full-arch implant-supported restorations (All-on-X appliances).
Formlabs’ Premium Teeth Resin
Premium Teeth Resin is a biocompatible, nano-ceramic-filled material with enhanced aesthetics that mimics natural teeth’s translucency and opalescence. Premium Teeth Resin parts are custom-designed for each patient’s intraoral anatomy and boast industry-leading aesthetics, optimal intraoral mechanical properties, accuracy, and a simple workflow, allowing for affordable, patient-specific dental care for a wide range of patient needs.
Premium Teeth Resin’s latest indication of temporary restorations, which is compatible with Form 3B+, Form 3BL, and Form 4B 3D printers, enables dental professionals to broaden their applications to a variety of patient-specific treatments with simplified workflows, lifelike aesthetics, and validated longevity to ensure 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.”
– Dr. Christopher Baer, DMD, Baer Dental
Formlabs is the industry leader in dental 3D printing, having printed over 15 million dental parts with its printers. Affordable and accessible 3D printing workflows and speciality materials lower the cost and labour barriers to dental 3D printing when compared to traditional methods, resulting in a surge 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.”
– Guillaume Bailliard, Formlabs President, Healthcare
Bailliard added, “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 Dental is a group of dental professionals committed to providing the best 3D printing solutions in the industry. It has impacted the lives of hundreds of thousands of patients, with 15 million dental parts printed on Formlabs printers. In addition to hardware, Formlabs offers a wide range of dental materials for use with Form 3B+, Form 3BL, and Form 4B 3D printers.
