FDA-Cleared OnX Tough 2: Revolutionizing Dentistry

In a groundbreaking development for the dental industry, SprintRay Inc., a leading player in digital dentistry and dental 3D printing solutions, has unveiled OnX Tough 2. This remarkable product is now the first and only 3D printing resin with the coveted FDA 510(k) clearance for fixed, implant-supported denture prosthetics. The launch of OnX Tough 2 signifies a pivotal moment, offering new possibilities in the world of dental restoration.

A Chairside Revolution

OnX Tough 2 is not just a resin; it’s a game-changer for dentists. It’s an integral part of an integrated, streamlined 3D printing chairside workflow that empowers dentists to create full-arch, fixed denture restorations. These restorations are characterized by their exceptional toughness and lifelike translucency, leading to high-quality smiles on the same day. With OnX Tough 2 and the SprintRay ecosystem, dental professionals can now 3D print up to 10 fixed dentures in just 30 minutes.

Meeting the Growing Demand

The demand for implant-supported dental prosthetics is on the rise, and it’s not showing any signs of slowing down. In fact, the market is expected to reach a staggering $11.54 billion in 2023. Unlike conventional removable dentures, fixed hybrid dentures are anchored securely using implants, drastically enhancing stability, functionality, and patient satisfaction.

Amir Mansouri, Ph.D., CEO, and Co-Founder of SprintRay, highlights the transformation this technology brings: “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.”

A New Era in Dentistry

OnX Tough 2 is not just a product; it’s a revolution in dentistry. It was formulated using the proprietary NanoFusion™ technology, a process that suspends the optimal amount of ceramic in the formulation. This minimizes mixing, enhances structural integrity, and makes restorations printed with OnX Tough 2 exceptionally tough and suitable for demanding dental applications like implant-supported dentures.

Moreover, OnX Tough 2 is available in shades Bleach, A1, and A2. It builds upon the chemistry from its predecessor resin, OnX Tough, and is formulated with new pigments for enhanced optical performance. These pigments offer high-precision shade matching and improved color stability. Fixed dentures printed with OnX Tough 2 possess optimal radiopacity for imaging diagnostics, treatment planning, and monitoring healing and progress.

Accessibility and Convenience for All

Implant-supported dentures can be life-changing for patients, improving their speech, chewing, facial balance, and aesthetics. However, the fabrication process has traditionally been time-consuming, resource-intensive, and labor-intensive, which deterred many from seeking this life-improving solution. Now, with the FDA-cleared OnX Tough 2 and the streamlined 3D printing chairside workflow, a new era of accessibility and convenience is upon us for both providers and patients.

Keith Klaus, DMD, an innovator in restorative, cosmetic, and implant dentistry, emphasizes the significance of this development: “FDA-cleared OnX Tough 2 and a streamlined 3D printing chairside workflow marks a watershed moment in the dental industry. It simplifies the process and ushers in a new era of accessibility and convenience for providers and patients alike.”


SprintRay’s launch of OnX Tough 2 represents a major step forward in the field of dentistry. It’s a breakthrough that simplifies and accelerates the creation of fixed, implant-supported dentures. With FDA clearance and innovative technology, it’s making same-day smiles a reality, and in doing so, it’s changing the lives of both dental professionals and their patients. To learn more about OnX Tough 2 and its incredible potential, visit SprintRay’s official website. Stay tuned for more updates as SprintRay presents details of this revolutionary technology at the American Academy of Implant Dentistry Conference in November 2023.

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