FDA Clears KeySplint Soft™ Printable Material

Posted on November 15, 2019

Keystone Industries® has obtained 510k clearance by the US 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 that is optimized exclusively for the Carbon® Digital Manufacturing Platform as well as an open-source version with a slight violet tint. The former is available exclusively through Zahn Dental.

Keystone’s patent-pending formulation provides a unique solution for dental labs and clinicians: a 3D printed night guard and splint that is flexible and comfortable, yet tough and durable, without brittleness.

“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 510k 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. 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.”

Keystone’s exclusive arrangement with Carbon on a clear version of KeySplint Soft is particularly noteworthy for users of the Carbon Digital Manufacturing Platform seeking high-quality, high-speed splint production.

“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 esthetic, best-in-class material for night guards and bite splint applications.”

The combination of the unique KeySplint Soft Clear resin and Carbon’s robust M series printers allows labs to produce 6x more splints than traditional production methods while increasing profit per unit by nearly 75%.

Early users have praised KeySplint Soft as a 3D solution the market has been seeking. Ashley Byrne, an experienced dental laboratory owner from Oxford, England, has been using KeySplint Soft Clear in his Carbon printers.

Byrne notes, “I’ve never used a material like it. I'm just blown away by how good it is. It is 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.”

Jay Patrick has spent years focusing on night guard and splint manufacturing, and now uses the Asiga Max (UV 385) for his 3D printing needs. After using KeySplint Soft, Jay remarked, “I honestly believe this will change printed splints forever. It has unbelievable fracture-resistance and mind-blowing elastic memory.”

Keystone Industries has validated KeySplint Soft in several printers and with several post-cure units, including printers from Carbon, Asiga, MiiCraft, and others, with additional validations ongoing regularly. Keystone updates its validations at https://keyprint.keystoneindustries.com/printer-validation/.

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, 3D printing KeySplint Soft yields a high quality, accurate and safe device at significantly reduced labor and material costs compared to other methods. With digital storage available, a lost or damaged splint can be re-printed easily, without any additional rework or patient visits.

For more information about KeySplint Soft and the entire KeyPrint line of 3D printing resins, visit https://keyprint.keystoneindustries.com/

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