Sonendo® receives FDA 510(k) Clearance for the next generation of the GentleWave® System
LAGUNA HILLS, Calif., March 28, 2016 (GLOBE NEWSWIRE) -- 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 increased 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 regimen when using the GentleWave System.”
For further information please visit, www.sonendo.com.
1Molina B et al. (2015) J Endod. 41:1701-05
Sonendo, Inc. is a privately-held, venture-backed company developing innovative and disruptive technologies to transform dentistry by Saving Teeth Through Sound Science®. The first commercially available product from Sonendo, the GentleWave® System, available in the US, shows significant improvements in clinical efficacy, and treatment efficiency when compared to conventional root canal techniques2-3. For more information please visit: www.sonendo.com.
2Molina B et al. (2015) J Endod. 41:1701-05. 3Haapasalo M et al. (2014) J Endod. 40:1178-81.
This announcement contains forward-looking statements that are based on management's beliefs, assumptions and expectations and on information currently available to management. All statements that address events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation our expectations with respect to the timing and progress of research and development activities. Management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on forward-looking statements because they speak only as of the date when made. Sonendo does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Actual results, developments or events could differ materially from those disclosed in the forward-looking statements.