Endodontic technology developer Sonendo has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the next generation of its GentleWave system.
Using the system, default or reduced treatment cycles can be chosen based on the practitioner's evaluation of a tooth for root canal treatment, according to the company. The system uses a proprietary Multisonic Ultracleaning technology that provides cleaning and disinfection in a single treatment visit.
"Gaining this additional clearance provides value and versatility to our endodontic customers and empowers them to apply their clinical judgment to determine the optimum treatment regimen when using the GentleWave system," stated Dan Miller, Sonendo's senior vice president of regulatory affairs, clinical affairs, and quality assurance, in a press release.
