BIOLASE (NASDAQ: BIOL), the global leader in dental lasers, and EdgeEndo, a global leader in commercializing endodontic products, announced today the FDA 510(k) clearance of the EdgePRO system for endodontists seeking a more 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.
The EdgePRO Laser-Assisted Microfluidic Irrigation device is built upon BIOLASE’s patented and proven platform, Er,Cr:YSGG 2780 nm wavelength laser technology, that has been shown to provide outstanding debridement1, cleaning, and disinfection by removing infected tissue, biofilms10,11, smear layer5-9, and killing up to 99% of bacteria commonly found in the root canal2-4, 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, which will capitalize on their unique ability to commercialize high-quality, innovative products within the endodontic specialty. EdgeEndo will commence selling the EdgePRO 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 with this enabling technology platform.
“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,” adds 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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2. Juric IB, Plecko V, Anic I. Antimicrobial Efficacy of Er,Cr:YSGG Laser-Activated Irrigation Compared with Passive Ultrasonic Irrigation and RinsEndo((R)) Against Intracanal Enterococcus faecalis. Photomedicine and Laser Surgery. 2014;32(11):600-605. doi:10.1089/pho.2014.3767
3. Betancourt, Sierra, Camps-Font, Arnabat-Domínguez, Viñas. Er,Cr:YSGG Laser-Activation Enhances Antimicrobial and Antibiofilm Action of Low Concentrations of Sodium Hypochlorite in Root Canals. Antibiotics. 2019;8(4):232. doi:10.3390/antibiotics8040232
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9. Peeters, Harry Huiz, and Ketut Suardita. “Efficacy of Smear Layer Removal at the Root Tip by Using Ethylenediaminetetraacetic Acid and Erbium, Chromium: Yttrium, Scandium, Gallium Garnet Laser.” Journal of Endodontics 37.11 (2011): 1585–1589. Web.
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