pixel

Safety Information

FDA Clearances and Registrations

  • Vivos Therapeutics is registered with the FDA as a Specification Developer.
  • Vivos mmRNA (Modified Mandibular Repositioning Nighttime Appliance) is FDA CLEARED as a Class II appliance for jaw repositioning and the treatment of mild-to-moderate sleep apnea and snoring in adults.
  • Vivos mRNA (Mandibular Repositioning Nighttime Appliance) is FDA CLEARED as a Class II appliance for the treatment of mild-to-moderate sleep apnea and snoring in adults.
  • Vivos DNA (Daytime Nighttime Appliance) is FDA REGISTERED as a Class 1 appliance for palatal expansion.
  • Vivos Guide Series (VStarter, VGrow, VWay) is FDA REGISTERED as Class 1 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.
  • Vivos Therapeutics, Inc. does not have products to treat children diagnosed with sleep disordered-breathing and/or OSA.