Sonendo has obtained 510(k) approval from the US Food and Drug Administration (FDA) for the second generation of its Multisonic ultracleaning system for root canal therapy.
The minimally-invasive device with disruptive technology uses multiple wavelengths of sound to clean the entire root canal system simultaneously.
Sonendo president and CEO Bjarne Bergheim said that the FDA clearance gives the company the right to market the system within the US.
"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.
Sonendo plans a limited launch of the Multisonic ultracleaning system in 2014.
The 510(k) approval is released through the FDA’s Center for Devices and Radiological Health.