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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