Sonendo® Receives 510(k) FDA Clearance For Its Multisonic Ultracleaning System Minimally-Invasive System Designed to Clean Entire Root Canal System Simultaneously
LAGUNA HILLS, Calif., May 27, 2014 /PRNewswire/ -- 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).
Sonendo, Inc. is a privately-held, venture-backed company developing innovative and disruptive technologies to transform endodontic therapy. In the United States alone, more than 17 million root canal procedures are performed each year. Sonendo aims to improve clinical quality and business economics of current root canal therapy. For more information please visit: www.sonendo.com.
This announcement contains forward-looking statements that are based on management's beliefs, assumptions and expectations and on information currently available to management. All statements that address events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation our expectations with respect to the timing and progress of research and development activities. Management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on forward-looking statements because they speak only as of the date when made. Sonendo does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Actual results, developments or events could differ materially from those disclosed in the forward-looking statements.