Biolase and EdgeEndo Announce FDA 510(k) Clearance of New Irrigation Device for Endodontists

Posted: January 6, 2022
Edited by Dentaltown staff

FOOTHILL RANCH, Calif.—Biolase and EdgeEndo have announced the FDA 510(k) clearance of the EdgePRO system, a system designed to provide an effective cleaning and disinfection alternative within root canal procedures. The new laser-assisted microfluidic irrigation device offers an advanced solution to current cleaning and disinfection techniques, without disrupting procedure workflow or adding substantial cost on a per-procedure basis. 

Biolase and EdgeEndo Announce FDA 510(k) Clearance of New Irrigation Device for Endodontists

The EdgePRO laser-assisted microfluidic irrigation device is built upon Biolase's patented platform, Er,Cr:YSGG 2780 nm wavelength laser technology, that has been shown to provide good debridement, cleaning and disinfection by removing infected tissue, biofilms, smear layer, and killing up to 99% of bacteria commonly found in the root canal, through the combination of advanced laser light-sound technology with traditional irrigation solutions.

Biolase will manufacture the EdgePRO system, consumable procedure tips and accompanying accessories for EdgeEndo. EdgeEndo will sell the system and related products immediately within the U.S. and will work closely with Biolase to ensure the needs of the endodontic community are satisfied. 

"This clearance enables endodontists to access state-of-the-art technology that has the potential to improve clinical outcomes and patient experiences. 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," said Dr. Charles Goodis, DDS, EdgeEndo founder, and CEO. "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."     

"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," added Biolase president and CEO John Beaver. "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."

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