OrthoFX Receives FDA Clearance for NiTime Aligners

Posted: April 17, 2023
Edited by Orthotown staff

FREMONT, Calif.— OrthoFX announced the U.S Food and Drug Administration (FDA) 510(k) clearance of their NiTime Aligners. OrthoFX's NiTime Aligner is the first aligner system that is explicitly designed for overnight wear. OrthoFX will exhibit NiTime Aligners at the American Association of Orthodontists Annual Meeting in Chicago at booth #641.

This aligner system reduces daily wear time to 9-12 hours without increasing the number of stages in the treatment. The Hyper-elastic polymer of the NiTime Aligners maintain biologically favored force levels, allowing predictable tooth movement with less wear time. Also multi-shell construction delivers optimal forces and a broad fit range to compensate for day-time movements.

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

For more information visit the OrthoFX booth at AAO or visit, orthofx.com.

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