Sonendo Gets FDA Green Light for Root Canal Cleaning System
Root canal devicemaker Sonendo said Monday it received 510(k) clearance from the FDA for tis third generation Multisonic Ultracleaning System for root canals, for use with the company’s GentleWave System.
The clearance expands the system’s use for root canal procedures, which can be used for anterior and pre-molar cases in addition to the current molar indication.
The system uses sound wavelengths to clean the entire root canal at the same time, the Laguna Hills, Calif., firm said.
Sonendo plans to launch the systems later this year, company President and CEO Bjarne Bergheim says. — Kellen Owings