SprintRay to Launch OnX Tough 2 FDA-Cleared 3D Printing Resin for Implant-Supported Dentures

Digital dentistry and 3D printing solutions company SprintRay Inc has introduced OnX Tough 2, a new 3D printing resin granted US Food and Drug Administration (FDA) 510(k) clearance for fixed, implant-supported denture prosthetics, according to a press release from the company.

OnX Tough 2 is designed to be a game-changer in the world of digital dentistry, featuring best-in-class fracture toughness and what is said to be lifelike esthetics, made possible by SprintRay's proprietary NanoFusion™ technology. This proprietary process suspends the optimal amount of ceramic in the formulation, minimizing mixing and enhancing structural integrity, according to SprintRay. The result is a resin suitable for demanding dental applications, particularly implant-supported dentures.

Dentists can now utilize an integrated, streamlined 3D printing chairside workflow with OnX Tough 2, allowing them to produce full arch, fixed denture restorations with desired toughness and optimal translucency for high-quality, same-day smiles, per the press release. This innovation enables dental professionals to 3D print up to 10 fixed dentures in just 30 minutes, providing a significant leap in efficiency compared to traditional methods.

Amir Mansouri, PhD, CEO, and Co-Founder of SprintRay, emphasized the transformative impact of this achievement, stating in the press release, "Traditional processes for fixed, implant-supported dentures involve up to 6 patient visits and extensive fabrication time. We were convinced there had to be a chairside approach. This achievement, marked by the first-ever FDA clearance for a 3D printing material for fixed hybrid dentures, ushers in a new era of same-day restorations while upholding the highest clinical standards, allowing patients to enjoy the benefits of their new smile immediately."

The demand for fixed, implant-supported dentures is driven by their ability to substantially improve stability, function, and patient satisfaction compared to conventional removable dentures.

Keith Klaus, DMD, a leader in restorative, cosmetic, and implant dentistry, hailed the FDA-cleared OnX Tough 2 as a "watershed moment in the dental industry" that simplifies the process and ushers in a new era of accessibility and convenience for all parties, making it a boon for any dental practice or lab. “Implant-supported dentures can be life-changing for patients, improving their speech, chewing facial balance, and esthetics, but the fabrication process is time-, resource-, and labor-intensive, deterring many from them. [OnX Tough 2] simplifies the process and ushers in a new era of accessibility and convenience for providers and patients alike.”

OnX Tough 2 introduces a new chemistry for dentistry, with formulations available in shades Bleach, A1, and A2. These shades, combined with NanoFusion technology, enhance structural integrity and deliver high-precision shade matching and improved color stability. The fixed dentures printed with OnX Tough 2 offer optimal radiopacity for imaging diagnostics, treatment planning, and monitoring healing and progress.

SprintRay is set to unveil the details of this new technology at the American Academy of Implant Dentistry Conference from November 1-4, 2023 at Caesar’s Palace in Las Vegas, Nevada. For more information about OnX Tough 2, visit SprintRay's official website.