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Wednesday, November 27, 2024

Formlabs’ Premium Tooth Resin receives FDA 510(ok) clearance



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Formlabs Dental’s Premium Tooth Resin has acquired FDA 510(ok) Medical System Clearance for 3D printing short-term single models of crowns, inlays, onlays, and veneers, and as much as seven-unit short-term bridges – enabling US Formlabs Dental customers to provide quite a lot of dental home equipment, all with one materials answer. These functions have been beforehand cleared within the EU.

Premium Tooth Resin is a nano-ceramic-filled biocompatible materials with enhanced aesthetics that mimics the translucency and opalescence of pure enamel. Customized-designed for every affected person’s intraoral anatomy, elements made with Premium Tooth Resin characteristic industry-leading aesthetics, optimum intraoral mechanical properties, accuracy, and a easy workflow to allow reasonably priced, patient-specific dental care for numerous affected person wants.

Since its launch in January, dentists have relied on Premium Tooth Resin to 3D print denture enamel and short-term full-arch implant-supported restorations. Accessible for Type 3B+, Type 3BL, and Type 4B 3D printers, Premium Tooth Resin’s latest indication of short-term restorations permits dental professionals to broaden their functions to a variety of patient-specific remedies with simplified workflows, life-like aesthetics, and validated longevity to ensure optimum scientific efficiency.

“Just lately, we had a affected person with a dental emergency. It was Friday afternoon, he’d misplaced an onlay we had positioned years in the past and was leaving on trip early the subsequent morning. Utilizing Premium Tooth Resin and Formlabs Type 4B 3D printer, we have been capable of rapidly 3D print a strong short-term restoration in simply 16 minutes. This fast turnaround wouldn’t have been potential with out the velocity of Type 4B and the effectiveness of Premium Tooth Resin,” stated Dr. Christopher Baer, DMD, Baer Dental.

Over 15 million dental elements have been printed with Formlabs Dental 3D printers. Inexpensive and accessible 3D printing workflows and specialty supplies cut back the price and labor limitations to dental 3D printing in comparison with conventional strategies, -sparking an increase in digital dentistry.

“At Formlabs, our aim is to develop the instruments and supplies that allow dentists to create patient-specific therapy plans for a variety of dental functions,” stated Guillaume Bailliard, President of Healthcare at Formlabs. “The FDA 510(ok) Clearance of Premium Tooth Resin for short-term crowns and bridges furthers our mission by increasing the capabilities of our resins to simplify workflows for dental professionals and supply one of the best outcomes for sufferers.”

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