Keystone Industries obtained 510k clearance by the U.S. FDA to sell its 3D printing night guard and splint resin in the United States, joining Canada and the EU as territories where KeySplint Soft can be purchased.
KeySplint Soft is a special 3D printing material. Without being brittle, it is tough and durable like a hard splint to withstand the forces of bruxism, yet flexible for patient comfort. It is abrasion and fracture resistant. KeySplint Soft is made in the USA, has 3 years of guaranteed shelf life, and is a highly-efficient and profitable way to make splints and night guards.
Keystone Industries has two shades available – an aesthetic clear version that is optimized exclusively for the Carbon Digital Manufacturing Platform as well as an open-source version with a slight violet tint.
Concerning the 510k clearance for KeySplint Soft, the FDA has not reviewed and cleared many 3D printing materials as medical devices, and KeySplint Soft is believed to be just the second FDA clearance for splint and night guard applications. In order to compliantly 3D print night guards or splints in the United States, users need to look for materials that have undergone and cleared the FDA 510k process.
The combination of the unique KeySplint Soft Clear resin and Carbon’s M series printers allows labs to produce 6x more splints than traditional production methods while increasing profit per unit by nearly 75%.
Keystone Industries validated KeySplint Soft in several printers and with several post-cure units, including printers from Carbon, Asiga, MiiCraft and others, with additional validations ongoing regularly.