Sonendo receives FDA clearance for next generation of GentleWave


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Dr. Randy W. Garland offers a presentation at the Sonendo booth at AAE16, the annual session of the American Association of Endodontists, held recently in San Francisco. (Photo: Sonendo)
Dental Tribune USA

By Dental Tribune USA

Tue. 26. April 2016


Sonendo announced recently that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the next generation of its GentleWave System. According to the company, 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, the company said.

“The increased versatility of this upgrade gives the endodontist control to treat the variety of clinical situations we are presented with,” said clinician Randy W. Garland, DDS, of Garland Endodontics in Encinitas, Calif.

According to Sonendo, 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 maintain as much structural integrity of the tooth as possible by removing less dentin.[1]

“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, Sonendo’s senior vice president, regulatory affairs, clinical affairs and quality assurance.

New website educates consumers

Sonendo has launched a patient-based website — — with the goal of helping patients make more informed decisions when considering root canal therapy.

According to Sonendo, the site explains that the GentleWave System facilitates a one-treatment root canal procedure and has the ability to outperform the clinical results obtained with conventional procedures, which can leave as much as 40 percent of treated root canals with bacteria.[2-5]

The site also presents research on the many patient-facing benefits of the GentleWave difference, such as the ability to deliver a higher standard of clean than may be achieved with conventional therapy, and patient testimonials regarding their GentleWave experience, the company said.

“We look forward to helping patients make informed decisions about their options when needing dental care,” said Chris Rabbitt, Sonendo’s chief commercial officer. “When considering root canal therapy, patients seek optimal outcomes that will quickly alleviate their pain and lead to saving their natural teeth with minimal disruption to their quality of life.

“Ultimately, we believe the GentleWave procedure aligns with these patient-centered goals and delivers on our mission of ‘Saving Teeth Through Sound Science’,” he said.

More information is available on Sonendo’s website,

(Source: Globe Newswire)

Note: A complete list of references is available from the publisher.

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