OrthoFX Receives FDA Clearance for NiTime Aligners



OrthoFX, a pioneer in the next generation of orthodontic aligners, announced the U.S Food and Drug Administration (FDA) 510(k) clearance of their NiTime Aligners.

OrthoFX’s NiTime Aligner is the first aligner system that is explicitly designed for overnight wear.


OrthoFX will exhibit NiTime Aligners at the American Association of Orthodontists Annual Meeting in Chicago at booth #641.

About NiTime Aligners

  • The first aligner system cleared by the FDA and supported by clinical studies that demonstrate treatment efficacy for reduced duration of wear.
  • The first aligner system that reduces daily wear time to 9 -12 hours without increasing the number of stages in the treatment.
  • The first patented aligner design optimized explicitly for nighttime wear.
    • Hyper-elastic polymer maintains biologically favored force levels, allowing predictable tooth movement with less wear time.
    • Multi-shell construction delivers optimal forces and a broad fit range to compensate for day-time movements.

Loc Phan, co-founder and VP of research and development said, “Our team of experts has worked tirelessly to create a solution effective for nighttime only wear. The ability to wear the aligners at night while patients sleep – makes the treatment journey much easier. The introduction of NiTime Aligner marks a significant milestone in our commitment to providing unique innovations to our doctors and their patients.”

NiTime Aligners will be available starting April 21st, 2023 to a limited initial group of orthodontic practices.

For more information visit the OrthoFX booth at AAO or click here.

OrthoFX will exhibit their full line of proprietary, patented polymer innovations including Rescue and Bright Aligners at AAO, booth #641.

About OrthoFX

The company was founded by a team of industry experts who played a critical role in building and scaling the clear aligner category. OrthoFX is pioneering next generation advancements in orthodontics and dental treatments through innovations in polymers, software and services. Learn more about our innovations and services here.

You can also sign up as a provider here.