Biolase and EdgeEndo Get 510(k) Clearance for EdgePRO Endodontic Irrigation Device

Dental laser manufacturer Biolase and endodontic devicemaker EdgeEndo have received the FDA’s 510(k) clearance for their EdgePRO system, a cleaning and disinfection device for endodontists performing root canals.

The laser-assisted microfluidic irrigation device, which uses Biolase's laser technology, is intended as an improvement to current root canal cleaning and disinfection techniques.

EdgePRO removes infected tissue and biofilms, killing up to 99 percent of bacteria commonly found in the root canal, according to the companies.