Keystone Industries (Gibbstown, N.J.) said today that it has obtained FDA 510k clearance to sell its resin for 3D-printed night guards and splints.
KeySplint Soft resin is durable enough to withstand the forces of bruxism and flexible enough for patient comfort, according to the company. Made in the U.S., the resin has three years of guaranteed shelf life and comes in two shades — a clear version that is optimized exclusively for the Carbon digital manufacturing platform and an open-source version with a violet tint.
“We worked for years to create a unique, safe, and effective night guard solution for 3D printing,” said Ira Rosenau, president of Keystone’s dental group, in a news release. “With the added production efficiency of 3D printing, KeySplint Soft offers a top-quality and unique splint solution that creates a significant value for the laboratory and a terrific protective device for the patient.”
The 510(k) clearance is just the second one for a 3D-printed resin for splints and night guards, according to Rosenau. The combination of KeySplint Soft Clear resin and Carbon’s M series printers allows labs to produce six times more splints than traditional production methods while increasing profit per unit by nearly 75%, he added.
“We’re excited that with the FDA clearance, we can now make the KeySplint Soft Clear material available to Carbon’s global network of dental partners and customers via the Carbon digital manufacturing platform,” said Brian Ganey, VP of Carbon’s oral health business. “We believe the KeySplint Soft Clear resin is the most aesthetic, best-in-class material for night guards and bite splint applications.”
Keystone Industries has validated KeySplint Soft in several printers and with several post-cure units, including printers from Carbon, Asiga, MiiCraft and others, with additional validations in the works.