Summary: OrthoFX has launched NiTime Clear Aligners, an advanced clear aligner polymer that requires only 9-12 hours of daily wear and has FDA 510(k) clearance. Featuring AirShell Technology for efficient tooth movement and minimal refinements, it will be showcased at the AAO Annual Meeting in New Orleans.

Key Takeaways:

  • Reduced Wear Time: NiTime Aligners are designed for a significantly shorter daily wear time of 9-12 hours without prolonging the overall treatment period.
  • Innovative Material: Utilizes a proprietary HyperElastic polymer with AirShell Technology, differentiating it from competitors who use standard materials like Zendura A and Zendura FLX.

OrthoFX announced its latest advanced clear aligner polymer, NiTime Clear Aligners. NiTime is a clear aligner system explicitly designed for shorter wear time and has received U.S. Food and Drug Administration (FDA) 510(k) clearance.

NiTime Clear Aligners

NiTime Clear Aligners are now available nationwide for doctors to treat all classes of dental malocclusions. OrthoFX will showcase the new material at the AAO (American Association of Orthodontists) Annual Meeting in New Orleans, May 3-6, 2024.

The NiTime Clear Aligner features:

  • Shorter Wear Time – Designed for 9 to 12 hours of shorter wear time without extended treatment duration
  • Greater Movement Efficiency – NiTime outperforms demonstrates up to 30% greater movement efficiency compared to other leading clear aligners, according to the company.
  • Predictable Precision – Designed for better predictability and compliance, OrthoFX says 92% of NiTime Aligner treatments were completed without refinements.
  • Nearly Eliminates Refinements – NiTime’s AirShell Technology have demonstrated an 86% predictability, nearly eliminating the need for refinements throughout the entire treatment plan, according to the company.

HyperElastic Polymer With AirShell Technology

OrthoFX’s HyperElastic polymer is designed to maintain biologically favored force levels, allowing predictable tooth movement with only 9 to 12 hours of wear time. It features AirShell technology, designed to provide sustained optimal forces delivery, supporting natural bone tissue remodeling at its natural pace to straighten teeth and to compensate against daytime relapse.

NiTime Aligners are designed to support favorable cellular physiology, fostering an ideal environment for biological tissue remodeling. This process involves the orchestrated activity of osteoclasts and osteoblasts, the key cells responsible for bone remodeling.

“NiTime Clear Aligners are truly the most advanced innovation the category has seen in polymer science in decades. OrthoFX is the only aligner manufacturer for this proprietary polymer material compared to leading aligner manufacturers who are using off the shelf materials like Zendura A and Zendura FLX,” said Ren Menon, OrthoFX co-founder. “Our patented technology behind NiTime Aligners make patient compliance effortless by reducing wear time in half, and nearly eliminating the need for extended treatment time given most cases do not need refinements.”