KEYSTONE INDUSTRIES
KeySplint Soft
One-of-a-kind 3D printing resin for the fabrication of flexible and durable dental splints and nightguards
A major concern in clinical practice is the wear resistance of resin materials used in dental prostheses and appliances.* However, the recent advent of 3D printing with the use of resins has provided practices with materials that offer ideal wear resistance. In addition, the 3D printing of night guards and splints, in particular, has resulted in lower manufacturing costs and lower printer prices.
KeySplint Soft from Keystone Industries is a unique biocompatible 3D printing resin for night guards and splints that is FDA 510(k)-cleared for sale in the United States. The patent-pending formulation provides a unique solution for dental labs and clinicians with a 3D printed night guard and splint that is flexible and comfortable, yet tough and durable, without brittleness.
“KeySplint Soft is a splint and night guard resin that is tough and durable, like a hard splint, to withstand the forces of bruxism. However, unlike a hard splint, it is not brittle, and remains flexible for patient comfort,” said Derek Keene, Vice President of Marketing for Keystone.
Cleared for 3D Printing Success
KeySplint Soft's robust formulation has a guaranteed 3-year shelf life, is color stable, and is validated in multiple open-source printers. “KeySplint Soft offers a highly efficient and streamlined way to manufacture splints and night guards with significantly reduced labor and material costs. There are thousands of dollars of profit in every bottle,” said Keene.
Keystone’s 510(k) clearance to sell KeySplint Soft is significant; it may be only the second FDA clearance for splint and night guard applications.
“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 510(k) process. We are pleased to be one of the first compliant splint solutions in the USA,” said Keystone President Ira Rosenau.
KeySplint Soft is available in 2 shades—KeySplint Soft Clear, an esthetic clear version optimized for the Carbon digital manufacturing platform; and KeySplint Soft, an open-source version with a slight violet tint.
See why KeySplint Soft represents a revolution when it comes to oral protective devices:
