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

Rhea-AI Summary

BIOLASE, Inc. (NASDAQ: BIOL) and EdgeEndo have received FDA 510(k) clearance for the EdgePRO Laser-Assisted Microfluidic Irrigation device, improving cleaning and disinfection in root canal procedures. This innovative system utilizes BIOLASE's patented Er,Cr:YSGG 2780 nm wavelength laser technology, ensuring effective removal of infected tissue and biofilms while maintaining cost efficiency. EdgeEndo will start selling the EdgePRO system in the U.S. immediately, reflecting a strong collaboration between the two companies aimed at elevating dental care quality.

Positive

• FDA 510(k) clearance received for the EdgePRO system, enhancing product credibility.
• EdgePRO utilizes advanced Er,Cr:YSGG laser technology for effective cleaning and disinfection.
• Immediate market launch by EdgeEndo, potentially increasing revenue streams for BIOLAS.

Negative

• None.

FOOTHILL RANCH, Calif., Jan. 6, 2022 /PRNewswire/ -- BIOLASE, Inc. (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, biofilms^10,11, smear layer^5-9, and killing up to 99% of bacteria commonly found in the root canal^2-4, 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."

To learn more about the new EdgePRO Laser-Assisted Microfluidic Irrigation Device EdgePro, visit edgeproendo.com  To learn more about the benefits of Waterlase technology in endodontics, visit biolase.com/betterendo.

About BIOLASE, Inc.

BIOLASE is a medical device company that develops, manufactures, markets, and sells laser systems in dentistry and medicine. BIOLASE's products advance the practice of dentistry and medicine for patients and healthcare professionals. BIOLASE's proprietary laser products incorporate approximately 271 patented and 40 patent-pending technologies designed to provide biologically and clinically superior performance with less pain and faster recovery times.

BIOLASE's innovative products provide cutting-edge technology at competitive prices to deliver superior results for dentists and patients. BIOLASE's principal products are revolutionary dental laser systems that perform a broad range of dental procedures, including cosmetic and complex surgical applications. BIOLASE has sold over 41,200 laser systems to date in over 80 countries around the world. Laser products under development address BIOLASE's core dental market and other adjacent medical and consumer applications.

For updates and information on Waterlase iPlus®, Waterlase Express™, and laser dentistry, find BIOLASE online at www.biolase.com, Facebook at www.facebook.com/biolase, Twitter at www.twitter.com/biolaseinc, Instagram at www.instagram.com/waterlase_laserdentistry, and LinkedIn at www.linkedin.com/company/biolase.

BIOLASE®, Waterlase® and Waterlase iPlus® are registered trademarks of BIOLASE, Inc.

About EdgeEndo

EdgeEndo is a medical device company with the mission to deliver high quality dental products and solutions at a substantially lower cost, which in turn benefits practitioners and patients everywhere. We are dedicated to the pursuit of bringing leading-edge products and the latest innovations to the industry. This thoughtful and modern business model is revolutionizing dental practices across the U.S. and the world.

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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SOURCE BIOLASE, Inc.

FAQ

What is the significance of the FDA 510(k) clearance for BIOL (NASDAQ: BIOL)?

The FDA 510(k) clearance allows BIOLASE to market the EdgePRO system, improving its credibility and potential sales in the dental sector.

How does the EdgePRO system differ from traditional endodontic cleaning methods?

The EdgePRO system combines laser technology with traditional irrigation solutions, offering more effective cleaning and disinfection without disrupting workflow.

When will the EdgePRO system be available for purchase?

EdgeEndo will start selling the EdgePRO system immediately in the U.S.

What technology does the EdgePRO system utilize?

The EdgePRO system uses BIOLASE's patented Er,Cr:YSGG 2780 nm wavelength laser technology.

Who manufactures the EdgePRO system?

BIOLASE manufactures the EdgePRO system and its consumable tips and accessories.