Sonendo announced that it has received 510(k) FDA Clearance for the first generation of its Multisonic Ultracleaning System which is set for commercial launch in 2014.
Using multiple sound wavelengths, the technology is designed to improve the clinical quality of endodontic procedures by providing a minimally invasive way to simultaneously clean an entire root canal system, according to a press release. The Multisonic Ultracleaning System is not yet commercially available, but Sonendo plans to launch the new technology next year.
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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. -- 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.