Sonendo® Receives 510(k) FDA Clearance For Its Multisonic Ultracleaning System™ System Designed to Improve Clinical Quality and Business Performance of Root Canal Therapy
LAGUNA HILLS, Calif., Sept. 3, 2013 /PRNewswire/ -- Sonendo®, the developer of a revolutionary technology for the endodontic marketplace, announced today that the company has received 510(k) FDA clearance for the first generation of its Multisonic Ultracleaning System™ set to launch in 2014. The device is designed to be a minimally invasive, disruptive technology that uses multiple wavelengths of sound to simultaneously clean the entire root canal system.
"This 510(k) clearance is an important milestone for Sonendo and puts us on the path for a commercial launch in 2014," said Bjarne Bergheim, President and Chief Executive Officer of Sonendo. "Our goal is to transform endodontics by improving the clinical quality and business performance of practices performing root canal therapy."
510(k) clearance is released through the Center for Devices and Radiological Health (CDRH) within the Food and Drug Administration (FDA). The clearance gives Sonendo the right to market the new medical device within the United States.
Sonendo's system is not yet commercially available.
Sonendo, Inc. is a privately-held, venture-backed company developing innovative and disruptive technologies to transform traditional endodontic therapy. The company aims to dramatically improve the current standard of care in endodontics by providing a faster, easier and better procedural result, while also increasing the level of patient comfort. In the United States alone, more than 15 million root canal procedures are performed each year. Sonendo investors include OrbiMed Advisors LLC, Themes Investment Partners, Fjord Ventures, and NeoMed Management. 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.