Keystone Industries has obtained 510k clearance by the U.S. FDA to sell KeySplint Soft, its 3D printing night guard and splint resin in the United States, joining Canada and the European Union as territories where KeySplint Soft can be purchased.
According to the company, Keystone’s patent-pending formulation for the KeySplint Soft printing material provides a unique solution for dental labs and clinicians: a 3D printed night guard and splint that is flexible and comfortable for the patient, yet tough and durable, without brittleness. It is reportedly abrasion, fracture, and stain resistant. KeySplint Soft is made in the United States, has 3 years of guaranteed shelf life, and can be used as a highly efficient and profitable way to make splints and night guards.
“We worked for years to create a unique, safe, and effective night guard solution for 3D printing,” says Ira Rosenau, president of Keystone’s dental group. “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.”
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.
Keystone’s exclusive arrangement with Carbon on a clear version of KeySplint Soft is particularly noteworthy for users of the Carbon Digital Manufacturing Platform seeking high-quality, high-speed splint production.
“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,” says Brian Ganey, Vice President of Carbon’s Oral Health Business.
According to Keystone, the combination of the unique KeySplint Soft Clear resin and Carbon’s robust M series printers allows labs to produce 6x more splints than traditional production methods while increasing profit per unit by nearly 75%.
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 ongoing regularly. Keystone updates its validations at https://keyprint.keystoneindustries.com/printer-validation/.