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, 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."
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
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Surgery 28.1 (2010): 103–108. Print.
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Er,Cr:YSGG Laser Irradiation in Removing the Smear Layer after Root
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(2016): 24. Web.
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9. Peeters, Harry Huiz, and Ketut Suardita. "Efficacy of Smear
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SOURCE BIOLASE, Inc.