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Safety Information

FDA Clearances and Registrations

  • Vivos Therapeutics is registered with the FDA as a Specification Developer.
  • Vivos C.A.R.E appliances (DNA, mRNA, mmRNA) are FDA Cleared Class II oral medical devices intended to treat moderate and severe obstructive sleep apnea in adults, 18 years of age and older along with the positive airway pressure (PAP) devices and/or myofunctional therapy, as needed.
  • Vivos DNA is cleared by the FDA, and intended to reduce nighttime snoring and to treat moderate to severe obstructive sleep apnea in children, 6-17 years of age who are diagnosed with snoring and/or moderate or severe obstructive sleep apnea and need orthodontic treatment.
  • Vivos Guide Series (VStarter, VGrow, VWay) are FDA registered as Class I appliances for tooth positioning.
    Vivos Therapeutics is registered as a repackager/relabeler with the FDA for the SleepImage System. SleepImage System is an FDA registered Class II device for measuring sleep quality.
  • Any use of a Vivos appliance outside of or “off label” from the FDA-cleared and/or registered indication(s) for use is the sole responsibility of the treating dentist at her/his clinical discretion and is not the teachings, guidelines, or recommendation of Vivos Therapeutics, Inc.