SprintRay Inc., a leader in digital dentistry and dental 3D printing solutions, announced the launch of OnX Tough 2, the first and only to receive US Food and Drug Administration (FDA) 510(k) clearance. This FDA cleared dental 3D printing resin with for fixed, implant-supported denture prosthetics, marks a significant step forward for the dental industry.
OnX Tough 2 is part of an integrated, streamlined chairside 3D printing workflow that allows dentists to create full arch, fixed denture restorations with unparalleled toughness and lifelike translucency for high-quality, same-day smiles. Dental professionals can 3D print up to ten fixed dentures in 30 minutes using OnX Tough 2 and the SprintRay ecosystem.
OnX Tough 2: A New FDA-Cleared Dental 3D Printing Resin
Implant-supported dental prosthetics are in high demand, with the market expected to reach $11.54 billion by 2023.1 Fixed hybrid dentures, as opposed to traditional removable dentures, are secured with implants, significantly improving stability, function, and patient satisfaction.
“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.”– Ph.D. Amir Mansouri, CEO and Co-Founder, SprintRay
New Chemistry for Dentistry
OnX Tough 2 was created using the company’s proprietary NanoFusion™ technology, which suspends the optimal amount of ceramic in the formulation while minimising mixing. This process improves structural integrity, making OnX Tough 2 restorations exceptionally tough and suitable for demanding dental applications such as implant-supported dentures.
The OnX Tough 2 3D printing resin is now available in the colours Bleach, A1, and A2. It builds on the chemistry of its predecessor resin, OnX Tough, and is formulated with new pigments for improved optical performance. These new pigments provide precise shade matching as well as improved colour stability. OnX Tough 2 fixed dentures have excellent 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. 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.”– Keith Klaus, DMD, an innovator in restorative, cosmetic, and implant dentistry with a private practice in Flowood, MS.
SprintRay will detail this new technology at the American Academy of Implant Dentistry Conference, which will be held November 1-4, 2023.
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