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.
Dr. Mark A. Latta D.M.D., M.S. conducted an independent wear study of several splint materials and issued a report titled A Laboratory Evaluation of Localized 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.”
The finished device is easy to clean, abrasion resistant, stain resistant, and easy to 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 USA, Canada and Europe in early May, 2021, with pre-sale options available in late April. Keep an eye on the Keystone Industries Facebook, Instagram, and Twitter pages for details.
“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, Keystone’s president of its 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. Keystone is constantly validating new printers, cure boxes, and workflows, so check back regularly to see if your printer has been added to our list of validations.
About Keystone Industries
Keystone’s group of dental companies focuses largely on consumable digital, laboratory, operatory, and preventative products. The company is a global supplier, maintaining a diverse network of more than 800 U.S. and international dental distribution partners in 70+ countries.
Keystone has developed industry-leading products such as its innovative KeyPrint line of 3D printing resins, Diamond D® high-impact denture base, and the Pro-Form® line of thermoplastics, innovative and patent-protected laboratory offerings such as Enamelite ceramic spray glazes, and the award-winning Gelato prophy paste. Keystone has spent nearly three decades formulating and producing biocompatible, cutting-edge, patented photopolymer resins for dental and cosmetic nail applications. Keystone maintains FDA licensing, ISO 13485 (medical device) and 22716 certifications, along with GMP certification and international product registrations.