Biolase (NSDQ: BIOL) and EdgeEndo today announced that the FDA has granted 510 (k) clearance for the EdgePRO system.
EdgePRO offers endodontists a cleaning and disinfection alternative in root canal procedures as a laser-assisted microfluidic irrigation device.
Biolase built the EdgePRO platform on its patented laser technology for debridement, cleaning and disinfection by removing infected tissue, biofilms, smears and removing up to 99% of bacteria commonly found in the root canal. The system combines advanced light-sound laser technology with traditional irrigation solutions, according to a press release.
“We are very pleased to have completed our first OEM project, received 510 (k) clearance from the FDA, and delivered EdgePro units to EdgeEndo in just 12 months,” said President and CEO. direction of Biolase. John Beaver said in the statement. “This achievement is a great example of cross-functional teamwork between our two market-leading companies, and we look forward to our long and valued relationship to come.”
Following FDA clearance, Biolase will manufacture EdgePRO systems, consumable procedural tips and associated accessories for EdgeEndo, which will market the product in the endodontic specialty. EdgeEndo will sell the EdgePRO System and related products immediately in the United States
“This clearance provides endodontists with access to cutting-edge technology that has the potential to improve clinical outcomes and patient experiences,” said EdgeEndo Founder and CEO Dr. Charles Goodis. “We remain committed to delivering products and solutions that can enhance the skills of specialists in providing the highest quality care to their patients while producing streamlined efficiencies for practices in a cost effective manner. We are proud to partner with Biolase, as part of our combined efforts to nurture and support the specialty with innovative and effective technologies that can improve the quality of dental care.