Sam Brusco, Associate Editor04.17.23
OrthoFX, a developer of next-gen orthodontic aligners, has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its NiTime aligners, the first aligner systems explicitly designed for overnight wear.
The NiTime aligner reduces daily wear time to nine to twelve hours without increasing the number of treatment stages. A hyper-elastic polymer maintains biologically favored force levels for predictable tooth movement with less wear time.
A multi-shell construction also delivers optimal forces and the aligners have a broad fit range to compensate for daytime movements.
Loc Phan, OrthoFX co-founder and VP of R&D, told the press, "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 21 to a limited initial group of orthodontic practices.
The NiTime aligner reduces daily wear time to nine to twelve hours without increasing the number of treatment stages. A hyper-elastic polymer maintains biologically favored force levels for predictable tooth movement with less wear time.
A multi-shell construction also delivers optimal forces and the aligners have a broad fit range to compensate for daytime movements.
Loc Phan, OrthoFX co-founder and VP of R&D, told the press, "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 21 to a limited initial group of orthodontic practices.