Keystone Industries® has obtained 510(k) clearance by the U.S. FDA to sell its revolutionary 3D printing night guard and splint resin in the United States, joining Canada and the EU as territories where KeySplint Soft can be purchased. KeySplint Soft is unlike any other 3D printing material. Without being brittle, it is tough and durable like a hard splint to withstand the forces of bruxism, yet flexible for patient comfort. It is abrasion and fracture resistant. KeySplint Soft is made in the USA, has 3 years of guaranteed shelf life, and is a highly-efficient and profitable way to make splints and night guards.

Keystone Industries has two shades available—an aesthetic clear version optimized exclusively for the Carbon Digital Manufacturing Platform—as well as an open-source version with a slight violet tint. KeySplint Soft Clear is designed for efficient, high-quality, high-speed splint production on the Carbon Digital Manufacturing Platform.

Carbon’s breakthroughs in oral health are powered by Carbon Digital Light Synthesis™ (DLS™) technology, which uses light and oxygen to rapidly produce high-quality, end-use products from a pool of liquid resin. Carbon’s innovations in software, hardware, and material science provide a platform for dental labs to produce next-generation, bespoke oral devices. The Carbon Platform significantly improves accuracy and efficiency while reducing time to design and manufacture.

Carbon’s technology and Keystone’s patent-pending formulation provide a unique solution for dental labs and clinicians – a 3D printed night guard and splint that is not only flexible and comfortable, without being brittle, but also tough and durable. “We worked for years to create a unique, safe, and effective night guard solution for 3D printing,” said Ira Rosenau, President of Keystone’s dental group. “With the added production efficiency of 3D printing, KeySplint Soft offers a top quality and unique splint solution that creates a significant value for the laboratory and a terrific protective device for the patient.”

Concerning the 510(k) clearance for KeySplint Soft, Mr. Rosenau noted, “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. So, 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 510(k) process. We are pleased to be one of the first compliant splint solutions here in the USA.”

The Carbon Digital Manufacturing Platform allows labs to produce up to 6X more splints than traditional production methods in the same amount of time while increasing profit per unit by up to 75%. “We’re excited that with the FDA clearance, we can now make the KeySplint Soft Clear material available to Carbon’s global network of dental partners and customers via the Carbon Digital Manufacturing Platform,” said Brian Ganey, Vice President of Carbon’s Oral Health Business. “We believe the KeySplint Soft Clear resin is the most aesthetic, best-in-class material for night guards and bite splint applications.”

Early users have praised KeySplint Soft Clear as a 3D solution the market has been seeking. Ashley Byrnes, an experienced dental laboratory owner from Oxford, England, has been using KeySplint Soft Clear in his Carbon printers. He notes, “I’ve never used a material like it. I’m just blown away by how good it is. It is aesthetically clear, soft but super strong, incredibly comfortable to wear, and printed on our Carbon M2 printers. Many splint materials are simply too brittle and break easily. However, this material is a game changer in the world of occlusal splints and keeps blowing our mind.”

Keystone has been a trusted dental manufacturer since 1908 and has developed an expertise over several decades in manufacturing photopolymer formulations. The KeyPrint® dental 3D printing solutions are manufactured in the USA and stocked in Keystone’s US and EU fulfilment centers.

Using its expertise in manufacturing both dental acrylics (like Diamond D® high-impact denture base) and night guards and splints (such as the industry-leading Pro-Form® line of thermoplastics), Keystone Industries has seen splint fabrication evolve from the tedious hand-crafting of cured acrylic splints to thermoforming laminate sheets over hand-poured stone models. With the digital dental revolution, of which Carbon is a leader, 3D printing KeySplint Soft Clear yields a high-quality, accurate, and safe device at significantly reduced labor and material costs compared to other methods. Carbon DLS™ technology offers on-demand manufacturability, opening new possibilities for dental labs small and large to take an inventory-in-the-cloud approach for products and replacement parts. With this digital storage available, a lost or damaged splint can be re-printed easily, without any additional rework or patient visits.