The FDA has cleared OrthoFX’s NiTime Aligners, a new aligner system designed for overnight use.

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

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

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

“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,” said Loc Phan, co-founder of OrthoFX and vice president of research and development. “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 21, 2023, to a limited initial group of orthodontic practices.

The company will exhibit its full line of proprietary, patented polymer innovations, including Rescue and Bright Aligners, at the AAO Annual Session.

OrthoFX was founded by a team of industry experts who played a critical role in building and scaling the clear aligner category. OrthoFX is developing next-generation advancements in orthodontics and dental treatments through innovations in polymers, software, and services.

Photo 75511104 © Vladimirfloyd |