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 United States (US) Food and Drug Administration approved the 510k application for KeySplint Hard on 9 April 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.
Dr Mark Latta DMD, MS, conducted an independent wear study of several splint materials and issued a report titled: “A Laboratory Evaluation of Localised Wear of Splint Materials.”
Traditional, milled and 3D printed splint options were tested. Dr Latta’s study concluded that, “The KeySplint Hard material exhibited excellent wear resistance – equal to the lab processed Lucitone 199. Further, the wear pattern suggests excellent wear resistance without tearing or cracking, suggesting excellent resistance to fatigue failure.”
Abrasion and stain resistant, the finished device is easy to clean and polish to ensure durability and beauty in every part. KeySplint Hard is 510k-cleared, CE marked (Class IIa) and Health Canada approved.
KeySplint Hard will launch in the US, Canada, and Europe in early May 2021, with pre-sale options available in late April.
“We are thrilled to have a full suite of FDA 510k-cleared 3D printing materials for the full array of night guard and splint therapies dental professionals seek for their patients,” noted Ira Rosenau, president of Keystone’s dental division.
As a member of the KeyPrint family, KeySplint Hard is an open-source resin, and will be validated in several printers, including the Asiga Max and Asiga Pro 4K, Carbon M2, Rapidshape dental printers, Sprintray Pro, NEXA dental printers and more.
