FDA grants 510k clearance to KeySplint Soft

The FDA has given 510k clearance for Keystone Industries to sell its 3D printing splint resin and night guard called the ‘KeySplint Soft’ in the US. It is already available in Canada and the EU.

Keystone’s product has a flexible design which is comfortable for patients, while still withstanding the forces of bruxism with its unique durability. Furthermore, it’s manufactured in the US and has a guaranteed shelf life of three years.

President of Keystone’s dental group, Ira Rosenau, stated: “This is a significant event in that 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. We are pleased to be one of the first compliant splint solutions here in the USA.”