• 27 May 2014
    Sonendo® Receives 510(k) FDA Clearance For Its Multisonic Ultracleaning System

    Sonendo®, Inc., the developer of a revolutionary technology for the endodontic marketplace, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the second generation of its Multisonic Ultracleaning System for root canal therapy. The system is designed to be a minimally-invasive, disruptive technology that utilizes multiple wavelengths of sound to clean the entire root canal system simultaneously.

    The FDA clearance gives Sonendo the right to market the system within the United States. Sonendo plans a limited launch in 2014, noted Bjarne Bergheim, President and Chief Executive Officer.

    “Our goal is to transform endodontics by improving the clinical quality and business performance of practices performing root canal therapy, and this FDA clearance has brought Sonendo one step closer to realizing this goal,” Bergheim said.

    510(k) clearance is released through the FDA’s Center for Devices and Radiological Health (CDRH).