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3D Stumbles Despite FDA Nod

3D Systems (NYSE:DDD) announced the U.S. Food and Drug Administration has provided 510(k) clearance for its NextDent Base material that is intended for the manufacturing of denture bases to support artificial teeth to form full or partial removable dentures. This material is approved by Health Canada and also received CE marking 1639.

NextDent Base is the third generation of the company’s denture base material for 3D printing and has excellent mechanical properties including high break resistance, and accurate and repeatable printability. NextDent Base is truly comparable to conventional denture materials and provides patients with long-lasting, impact-resistant dentures. Additionally, the material is available in four colors to match the most popular gingiva shades for improved aesthetics. Using NextDent Base as part of 3D Systems’ digital dental workflow is helping drive new levels of speed, productivity, efficiency, and precision while also providing opportunities to improve the patient experience.

NextDent Base is already receiving positive feedback in the market. The company has been running trial tests with the material and one official stated, “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. 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.”

DDD shares lost a dime, or 2.1%, to $4.58.