Biolase (NSDQ:BIOL) and EdgeEndo announced today that the FDA granted 510(k) clearance to the EdgePRO system.
EdgePRO offers endodontists a cleaning and disinfection alternative within root canal procedures as a laser-assisted, microfluidic irrigation device.
Biolase built the EdgePRO platform upon its patented laser technology for debridement, cleaning and disinfection through the removal of infected tissue, biofilms, smear layer and the killing of up to 99% of bacteria commonly found in the root canal. The system combines advanced laser light-sound technology with traditional irrigation solutions, according to a news release.
“We’re very pleased to complete our first OEM project, receive FDA 510(k) clearance, and deliver EdgePro units to EdgeEndo in only 12 months,” Biolase President & CEO John Beaver said in the release. “This achievement is an excellent example of cross-functional teamwork between our two market-leading companies, and we look forward to our long and valuable relationship ahead.”
Following FDA clearance, Biolase will manufacture the EdgePRO systems, consumable procedure tips and accompanying accessories for EdgeEndo, which will commercialize the product within the endodontic specialty. EdgeEndo will sell the EdgePRO system and related products immediately within the U.S.
“This clearance enables endodontists to access state-of-the-art technology that has the potential to improve clinical outcomes and patient experiences,” EdgeEndo Founder & CEO Dr. Charles Goodis said. “We remain committed to offering products and solutions that may enhance specialist skills in providing the highest quality of care for their patients while producing streamlined efficiencies for practices in a cost-effective manner. We are proud to partner with Biolase, in our combined effort to service and support the specialty with innovative and effective technologies that may elevate the quality of dental care.”