3D Systems Gains FDA Clearance for 3rd Generation NextDent® Base 3D Printing Resin

3D Systems announced that it has received FDA 510(k) clearance for the manufacturing of denture bases, supporting artificial teeth for the creation of full or partial removable dentures using the NextDent® Base material.

NextDent Base is the third generation of the company's denture base material which has been optimized to offer desired mechanical properties including high break resistance and precise and repeatable printability. This material’s durable and impact-resistant physical properties make it a suitable alternative to traditional denture base materials and production workflows. With optimal esthetic outcomes in mind, NextDent Base is available in 4 common gingiva shades.

In a press release announcing the FDA 510(k) clearance, 3D Systems says incorporating NextDent Base into te company’s digital dental workflow enhances speed, productivity, efficiency, and precision. The release also included positive feedback from dental professionals who tested the material.

“This new material is truly amazing! No support bar across the heels, lovely delicate supports which are easy to remove, and the fit of the teeth to denture and denture to bar show just how stable this is,” says Steven Campbell, RDT, FCGDent,from Nexus Dental Laboratory in Harrogate, UK. “We have just started trials with it, but already I can see the strength of this is going to make it an incredible material to keep an eye on. We are so confident in the strength we see on early prints that we are going to run some test partials with it.”

The press release also included a quote from Kunal Lal, DDS, MS, Board Certified Prosthodontist at LAL Dental in New York, who emphasized the benfits of the material’s flexibility in thinner sections and suitability for same-day interim RPD fabrication.

NextDent Base joins 3D Systems' extensive lineup of NextDent resins. With 30 different Nextdent resins, 3D Systems offers the largest resin selection available from any dental 3D printing material supplier.

“Our goal is to ensure we are addressing our customers’ needs with our solutions, and this is yet another step in achieving that goal,” Chuck Stapleton, vice president and general manager, dental, 3D Systems, says in the press release. “With the clearance of NextDent Base, we continue to add to our portfolio of dental 3D printing materials that are enabling dental laboratories and clinics to address a wide range of applications. These offerings are helping our customers accelerate the adoption of additive manufacturing as part of their workflows and drive new levels of speed, productivity, efficiency, and precision while also providing opportunities to improve the patient experience.”

NextDent Base is also approved for use in the European Union, Canada, and other regions of the globe. NextDent 3D printing materials for medical devices, including NextDent Base, are biocompatible and CE-certified in accordance with Medical Device Directive 93/42/EEC. These materials are listed with the FDA and registered in various other countries.