SprintRay, an industry leader in digital dentistry and dental 3D printing solutions, has launched OnX Tough 2, the first and only 3D printing resin with US Food and Drug Administration (FDA) 510(k) clearance for fixed, implant-supported denture prosthetics – marking a major step for the dental industry.
OnX Tough 2 is part of an integrated, streamlined 3D printing chairside workflow enabling dentists to produce full arch, fixed denture restorations with unparalleled toughness and lifelike translucency for high-quality, same-day smiles. With OnX Tough 2 and the SprintRay ecosystem, dental professionals can 3D print up to 10 fixed dentures in 30 minutes.
The need for implant-supported dental prosthetics is on the rise, with the market expected to reportedly grow to $11.54 billion in 2023. Unlike conventional removable dentures, fixed hybrid dentures are secured using implants, substantially improving stability and function.
“Traditional processes for fixed, implant-supported dentures involve up to 6 patient visits and extensive fabrication time,” said Amir Mansouri, Ph.D., CEO and Co-founder of SprintRay. “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.”
OnX Tough 2 was formulated using proprietary NanoFusion technology, a process that suspends the optimal amount of ceramic in the formulation, which minimizes mixing. This process enhances structural integrity, making restorations printed with OnX Tough 2 exceptionally tough and suitable for demanding dental applications like implant-supported dentures.
Now available in shades Bleach, A1, and A2, OnX Tough 2 builds upon the chemistry from its predecessor resin, OnX Tough, and is formulated with new pigments for enhanced optical performance. These new pigments deliver high-precision shade matching and improved color stability. Fixed dentures printed with OnX Tough 2 have optimal radiopacity for imaging diagnostics, treatment planning, and monitoring healing and progress.
“Implant-supported dentures can be life-changing for patients, improving their speech, chewing, facial balance, and aesthetics, but the fabrication process is time-, resource-, and labor-intensive, deterring many from them,” said Keith Klaus, DMD, an innovator in restorative, cosmetic, and implant dentistry with a private practice in Flowood, Mississippi. “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.”