Home » FDA Clears OrthoFX Orthodontic Nighttime Aligners
FDA Clears OrthoFX Orthodontic Nighttime Aligners
The FDA has granted 510(k) clearance to OrthoFX’s NiTime Aligners overnight orthodontic retainer.
The retainer reduces daily wear time to 9 to 12 hours without increasing treatment time, the company says. Made of hyper-elastic polymer, the device maintains biologically favored force levels and allows predictable tooth movement.
The device is also designed with a broad fit range, to compensate for daytime tooth movement.
The company’s NiTime Aligners will be made available starting on April 21 to a limited initial group of orthodontic practices.
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