Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K213428
    Device Name
    EdgePro
    Manufacturer
    Biolase Inc.
    Date Cleared
    2021-12-22

    (62 days)

    Product Code
    NVK, GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Biolase Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Root Canal Hard Tissue Indications (for use on adult and pediatric patients) - Root canal preparation including enlargement - Root canal debridement and cleaning Root Canal Disinfection (for use on adult and pediatric patients) - Laser root canal disinfection after endodontic treatment
    Device Description
    EdgePro is an erbium, chromium: yttrium, scandium, gallium garnet (Er,Cr: YSGG)solid-state laser that provides optical energy to the user-controlled distribution of atomized water droplets at 2780 nm. The laser system consists of a top-table console which houses the laser head, power supply, cooling system, micro-processor and a removable tablet PC as a control panel. A flexible fiber cable, connected to the laser console, delivers laser energy to the treatment site through a laser tip attached to a Handpiece. A visible light emitted from the Handpiece head illuminates the area. The laser is activated by means of a wireless footswitch. Various laser tips are available for different clinical applications. EdgePro utilizes advanced laser and water atomization technologies to cut, shave, contour, roughen, etch and resect oral hard tissues, and direct laser energy, with or without water for cooling and hydration, to perform oral soft tissue removal, incision, excision, ablation and coagulation as well as specific endodontic and periodontal applications.
    Ask a Question

    Page 1 of 1