Sonendo, a developer of endodontic products, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the first generation of its Multisonic Ultracleaning System, set to launch in 2014.
The device is minimally invasive and uses multiple wavelengths of sound to simultaneously clean the entire root canal system, the company explained in a press release.
The FDA clearance gives Sonendo the right to market the new medical device within the U.S. The system is not yet commercially available.
