Formlabs Dental, the dental business unit of Resin 3D printer manufacturer Formlabs, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Premium Teeth Resin.
Dental professionals in the US can now use the resin to 3D print temporary single units of crowns, inlays, onlays, veneers, and up to seven-unit temporary bridges. The material has already been cleared for these applications in the EU.
According to Guillaume Bailliard, Formlabs President of Healthcare, the new FDA clearance furthers the company’s goal of simplifying clinical workflows and improving patient outcomes.
“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,” explained Bailliard.
The company is one of the biggest players in the dental 3D printing space. Over 15 million dental parts have been produced using Formlabs Dental 3D printers.
Formlabs’ Premium Teeth Resin receives FDA clearance
Launched in January 2024, Premium Teeth Resin is a nano-ceramic-filled biocompatible material for realistic dental components that mimic the translucency and opalescence of natural teeth.
Compatible with Form 3B+, Form 3BL, and Form 4B 3D printers, the resin is now cleared for use in the USA, EU, UK, Switzerland, and Canada.
Parts made with the material can be customized for each patient’s intraoral anatomy, allowing it to cater to diverse patient needs. According to Formlabs Dental, it offers industry-leasing aesthetics, optimal intraoral mechanical properties, high accuracy, and a simple workflow at an affordable price.
Since its launch, Premium Teeth Resin has been used to 3D print denture teeth and temporary full-arch implant-supported restorations in clinical settings. Dr. Christopher Baer, DMD, Baer Dental, has attested to the value of the newly cleared dental 3D printing material.
“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,” Baer explained. “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.”
According to Baer, such an efficient turnaround would not have been possible without the Form 4B’s speed and the effectiveness of Premium Teeth Resin.
The growth of dental 3D printing
At the start of the year, a survey on 3D printing trends saw industry experts argue that the adoption of 3D printing within the dental industry will continue to grow. The industry is expected to move from indirect production for mold creation to the direct 3D printing of dental devices and appliances.
Earlier this year, Desktop Health, Massachusetts-based industrial 3D printer manufacturer Desktop Metal (DM) ‘s healthcare business unit introduced a new formulation of its Flexcera material.
Called Flexcera Base Ultra+, the 3D printer resin is optimized for producing 3D printed gingiva components of full and partial removable dentures. A nano-ceramic composite material, the new formulation enables 2.5 mm wall thickness and 1 mm socket thickness. This is said to improve durability and facilitate a better fit for patients. The resin is reportedly 50% stronger than its predecessors, possessing 70% greater resistance to deformation than ISO standards.
Flexcera Base Ultra+ has received FDA 510(k) Class II approval and is a CE Marked and MDR Class I-certified medical device.
Elsewhere, microscale 3D printer manufacturer Boston Micro Fabrication made its dental debut last year with the launch of UltraThineer. Billed as the “world’s thinnest cosmetic dental veneer,” this product is produced using the company’s projection micro stereolithography (PµSL) technology.
The 3D printed veneers are designed to be three times thinner than their conventionally manufactured counterparts. This reportedly drastically reduces the preparatory steps required by dental practitioners.
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Featured image shows a dental component 3D printed using Formlab Dental’s Premium Teeth Resin. Photo via Formlabs.
