FDA grants 510(k) clearance for Sonendo’s Multisonic Ultracleaning system
The US Food and Drug Administration (FDA) has granted 510(k) clearance for Sonendo's third generation Multisonic Ultracleaning system for root canal therapy.
The US Food and Drug Administration (FDA) has granted 510(k) clearance for Sonendo's third generation Multisonic Ultracleaning system for root canal therapy.
Released through the FDA's Center for Devices and Radiological Health, the clearance expands the use for the GentleWave system to include anterior and premolar cases, apart from the current molar indication.
Sonendo president Bjarne Bergheim said approval gives the company the right to market the system within the US.
"The system is designed to be a minimally-invasive, disruptive technology that leverages multiple wavelengths of sound to clean the entire root canal system simultaneously."
Bjarne Bergheim said: "Sonendo plans a phased launch of its third generation GentleWave system in 2015."
The system is designed to be a minimally-invasive, disruptive technology that leverages multiple wavelengths of sound to clean the entire root canal system simultaneously.
Sonendo plans to launch the latest generation of the GentleWave system at the American Academy of Endodontics annual meeting, which is scheduled to be held between 6-9 May at the Washington State Convention Centre in Seattle, US.
The privately-held, venture-backed company is developing a range of innovative and disruptive technologies to transform root canal procedures.
Image: An X-ray of a root canal therapy. Photo: courtesy of Dr Jeffrey Cross DDS.