Sonendo today announced it received Health Canada regulatory approval for its next-generation GentleWave G4 system for root canal treatment.
The new Health Canada approval expands the Laguna Hills, California–based company’s suite of products in Canada to bring the GentleWave G4 system’s more modern design to the market.
The system uses broad-spectrum acoustic energy and advanced fluid dynamics to deliver advanced disinfection to penetrate complex anatomies, resulting in better cleaning and improved healing times. Sonendo launched the system on October 18.
Sonendo’s GentleWave procedure is used in root canal treatment for a minimally invasive process to preserve tooth structure and promotes early healing. In a recent clinical trial, 99.5% of patients experienced minimal to no pain in the GentleWave procedure with the addition of its CleanFlow technology.
“We are excited about introducing the GentleWave G4 System to our customers and the endodontic community in Canada,” Chief Commercial Officer Michael Smith said in a news release. “We believe the GentleWave G4 System offers endodontic practices and their patients an elevated experience that also reinforces our commitment to commercial support and expansion in Canada.”
More about Sonendo
Sonendo is a commercial-stage medtech company. The company’s focus is on technologies to save teeth from tooth decay. Its GentleWave system can clean and disinfect microscopic spaces within teeth without the need to remove tooth structure. The system’s proprietary mechanism of action combines procedure fluid optimization, broad-spectrum acoustic energy and advanced fluid dynamics.
Sonendo is also the parent company of TDO Software, a developer of endodontic practice management software to simplify practice workflow.