OrthoFX introduces NiTime Aligners, the First FDA-Cleared Nighttime-Only Aligner System

OrthoFX, an orthodontic aligners manufacturer, announced that their NiTime Aligners have received 510(k) clearance from the U.S Food and Drug Administration (FDA). 

NiTime Aligner is the first aligner system explicitly designed for overnight wear, reducing daily wear time to 9-12 hours without increasing the number of stages in the treatment. This aligner system is supported by clinical studies that demonstrate treatment efficacy for reduced duration of wear, says OrthoFX.

OrthoFX will showcase the NiTime Aligners at the American Association of Orthodontists Annual Meeting in Chicago, from April 21-25, 2023, at booth #641. This will be the first time that NiTime Aligners will be introduced to the orthodontic market.

Patented Design for Nighttime Wear

NiTime Aligners have a patented aligner design optimized for nighttime wear. The hyper-elastic polymer used in this aligner system maintains biologically favored force levels, allowing predictable tooth movement with less wear time. According to the manufacturer, the multi-shell construction delivers optimal forces and a broad fit range to compensate for day-time movements.

According to Loc Phan, Co-founder and VP of Research and Development, “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.”

Benefits of the NiTime Aligners

The design of NiTime aligners reportedly provides them the capability to generate results with light continuous forces, just like a heat-activated Ni-Ti wire. The multi-shell benefit allows these aligners to have up to 5x better elongation to yield for a wider span to move teeth according to the plan. 

In addition, according to a press release, the NiTime aligner system is designed to counter relapses and is equipped with anti-relapse technology, the ability to easily fit dentition up to +4 stages to counteract unplanned deviations for effective night time treatments.

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

Click here for more information on the NiTime Aligners by OrthoFX.