Limited by Federal (or United States) law to investigational use.”
The AcceleDent System is currently in a randomized controlled clinical trial at the University of Texas Health Science Center in San Antonio. This trial was enrolled under an Investigational Device Exemption. FDA will be reviewing the AcceleDent System, which is regulated as a medical device. If clearance is granted, the product will be available at an orthodontist near you.
The AcceleDent System is CE Marked for sale for its intended purpose as a medical device within the European Union. The AcceleDent System has been included in the Australian Register of Therapeutic Goods (ARTG 166667 Class IIa). AcceleDent is currently available in Great Britain, Australia, and Hungary.
