The Food and Drug Administration (FDA) has given Sonendo’s next-generation GentleWave System 510(k) clearance. Now, endodontists can choose between using the default treatment cycles or reducing treatment cycles as desired based on their evaluation of a tooth for root canal treatment using the GentleWave System, the company says.
“The increased versatility of this upgrade gives the endodontist control to treat the variety of clinical situations that we are presented with,” said Randy W. Garland, DDS, of Garland Endodontics in Encinitas, Calif.
The GentleWave System’s proprietary Multisonic Ultracleaning technology is designed to enable endodontists to deliver unsurpassed cleaning and disinfection in a single treatment. Also, Sonendo reports that the GentleWave System maintains as much of the tooth’s structural integrity as possible by removing less dentin.
“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,” said Dan Miller, senior vice president of regulatory affairs, clinical affairs, and quality assurance at Sonendo.
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