Foothill Ranch, Calif.-based dental laser company Biolase and medical device company EdgeEndo were granted FDA 510(k) clearance for their EdgePRO irrigation system, Biolase said Jan. 6.
The laser-assisted EdgePro device provides endodontists a disinfecting alternative for root canals. It removes infected tissue, biofilms and smear layers while killing up to 99 percent of bacteria in the root canal.
Biolase will begin manufacturing the system, while EdgeEndo will sell it in the U.S.