The makers of KeySplint Soft announce that its newest resin, KeySplint Hard, has been 510k-cleared by the U.S. Food and Drug Administration.
Gibbstown, NJ – Keystone Industries has completed the KeySplint family with KeySplint Hard, a biocompatible 3D printing resin designed for high-strength rigid dental splints and night guards. The U.S. Food and Drug Administration approved the 510k application for KeySplint Hard on April 9, 2021.
Through Keystone’s rigorous approach, KeySplint Hard brings the same level of accuracy, durability, and innovation as KeySplint Soft to rigid splints. KeySplint Hard provides users with comparable strength to other hard splint materials, but with added durability over time due to its unique properties, including elongation at break.…