Thursday, December 8, 2022

BIOLASE and EdgeEndo Announce FDA 510(k) Clearance of New EdgePRO Laser-Assisted Microfluidic Irrigation Device for Endodontists

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.”

More here.


1. Montero-Miralles P, Torres-Lagares D, Segura-Egea J-J, Serrera-Figallo M-A, Gutierrez-Perez J-L, Castillo-Dali G. Comparative study of debris and smear layer removal with EDTA and Er,Cr:YSGG laser. Journal of Clinical and Experimental Dentistry. 2018;10(6):598-602. doi:10.4317/jced.54936
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
4. Gordon W, Atabakhsh VA, Meza F, et al. The antimicrobial efficacy of the Er,Cr:YSGG laser with radial emitting tips on root canal dentin walls infected with E faecalis. JADA. 2007;138(July):992-1002. doi:10.14219/jada.archive.2007.0297
5. Silva, Anna Cristina Biella et al. “Analysis of Permeability and Morphology of Root Canal Dentin After Er,Cr:YSGG Laser Irradiation.” Photomedicine and Laser Surgery 28.1 (2010): 103–108. Print.
6. Madhusudhana, Koppolu et al. “Effect of Endoactivator and Er,Cr:YSGG Laser Irradiation in Removing the Smear Layer after Root Canal Instrumentation: An in Vitro Study.” Journal of Dr. NTR University of Health Sciences 5.1 (2016): 24. Web.
7. Soares, Flavio et al. “Impact of Er,Cr:YSGG Laser Therapy on the Cleanliness of the Root Canal Walls of Primary Teeth.” Journal of endodontics 34.4 (2008): 474–7. Web. 25 Jan. 2012.
8. Ishizaki, Nelson Tatsunari et al. “Thermographical and Morphological Studies of Er,Cr:YSGG Laser Irradiation on Root Canal Walls.” Photomedicine and laser surgery 22.4 (2004): 291–7. Web.
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.
10. Schoop, U et al. “The Impact of an ErCrYSGG Laser with Radial-Firing Tips on Endodontic Treatment.” Lasers in medical science 24.1 (2009): 59–65. Web. 5 Dec. 2011.
11. Arnabat, Josep et al. “Bactericidal Activity of Erbium, Chromium: Yttrium–scandium–gallium–garnet Laser in Root Canals.” Lasers Medical Science 25 (2010): 805–810. Web.


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