news

  • 28 March 2016
    SonendoŽ receives FDA 510(K) clearance for the next generation of the GentlewaveŽ System

    Sonendo announced today that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the next generation of it’s GentleWave® System. This clearance provides the endodontist with the choice of using the default treatment cycles or reducing the treatment cycles as desired based on their evaluation of a tooth for root canal treatment using the GentleWave System. This most recent FDA clearance is in alignment with Sonendo’s commitment to develop products that improve clinical efficacy, treatment efficiency, and practice economy for the endodontist. Randy W. Garland, DDS, Garland Endodontics, Encinitas, CA, stated “The increase versatility of this upgrade gives the Endodontist control to treat the variety of clinical situations we are presented with.”

    The GentleWave System represents an entirely new way of thinking about root canal therapy by applying a proprietary Multisonic UltracleaningTM technology, which provides the endodontist the ability to deliver unsurpassed cleaning and disinfection in a single treatment visit. In addition, the GentleWave System helps the Endodontist in their goal to maintain as much structural integrity of the tooth as possible by removing less dentin1.

    Dan Miller, Senior Vice President, Regulatory Affairs, Clinical Affairs and Quality Assurance, stated “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 regiment required to achieve clinical efficacy when using the GentleWave System.”