![]() ![]() In case of emergency, keep the microscope oculars and mounting accessories in the cart top drawer. Use of polarized prescription glasses will cause the 3D effect to be distorted. When operating in 3D, to ensure optimal image quality, use only approved passive-polarized glasses. PRECAUTIONS: Do not touch any system component and the patient at the same time during a procedure to prevent electric shock. There are no known contraindications for use of this device. WARNINGS: The system is not suitable for use in the presence of flammable anesthetics mixture with air or oxygen. ![]() It acts as an adjunct to the surgical microscope during surgery displaying real-time images or images from recordings. INDICATION: The NGENUITY ® 3D Visualization System consists of a 3D stereoscopic, high-definition digital video camera and workstation to provide magnified stereoscopic images of objects during micro-surgery. To learn more about the new EdgePRO Laser-Assisted Microfluidic Irrigation Device EdgePro, visit To learn more about the benefits of Waterlase technology in endodontics, visit /betterendo.CAUTION: Federal (USA) law restricts this device to sale by, or on the order of, a physician. “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.” “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.” Charles Goodis, DDS, EdgeEndo founder, and CEO. 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. “This clearance enables endodontists to access state-of-the-art technology that has the potential to improve clinical outcomes and patient experiences. ![]() and will work closely with BIOLASE to ensure the needs of the endodontic community are satisfied with this enabling technology platform. ![]() EdgeEndo will commence selling the EdgePRO system and related products immediately within the U.S. 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 debridement 1, 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.īIOLASE 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. 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. 6, 2022 – BIOLASE, Inc., the global leader in dental lasers, and EdgeEndo, a global leader in commercializing endodontic products, announced today the FDA 510(k) clearance of the Ed gePRO system for endodontists seeking a more effective cleaning and disinfection alternative within root canal procedures. ![]()
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