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510(k) Data Aggregation

    K Number
    K232551
    Device Name
    EM-07 Cordless Endo Motor
    Manufacturer
    Forum Engineering Technologies (96) Ltd.
    Date Cleared
    2024-07-09

    (321 days)

    Product Code
    EKX, LQY
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Forum Engineering Technologies (96) Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EM-07 is a cordless handpiece with apex localization capability, used for driving files in both continuous rotation and reciprocating mode during an endodontic procedure for enlargement of root canals, while monitoring the position of the endodontic file tip within the canal.
    Device Description
    The EM-07 is a cordless handpiece with apex localization capability.
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    K Number
    K111474
    Device Name
    BINGO PRO
    Manufacturer
    FORUM ENGINEERING TECHNOLOGIES (96) LTD.
    Date Cleared
    2011-11-02

    (159 days)

    Product Code
    LQY
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    FORUM ENGINEERING TECHNOLOGIES (96) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BINGO PRO is an electronic device used for precise apex localization and working length determination during root canal treatment. The device enables to obtain correct results in canals with different conditions - dry or wet.
    Device Description
    BINGO PRO is a modern apex locator intended for precise localization of root canal apex. The measurements in BINGO PRO are performed utilizing AC signals at two frequencies -500 Hz and 8 kHz. The frequencies are alternated and not mixed, eliminating the need for signal mixing and frequency discrimination electronic circuits. The patented signal measuring method utilized in BINGO PRO is based on measurements of RMS (Root Mean Square) level of the signal. Advanced 3D user interface implemented in BINGO PRO is based on high resolution TFT color graphic display. "Live" real time presentation of endodontic file movement inside the canal is designed to make dentist's work easier and to increase his confidence. Display indicators are carefully designed to be intuitively understood and to serve for instant troubleshooting during device usage. BINGO PRO shows the movement of the file inside the canal from the beginning of the measurements to the end, providing uninterrupted feedback to the dentist. ROOT WIZARD file tracking algorithm enables full-scale display of the file movement during the treatment while APICAL ZOOM feature enables high-resolution display of the file advance in preapical and apical zones. Large, clearly recognizable graphical and numerical readings in the APICAL ZOOM are designed to enable precise control over the file advance matching the individual technique of the dentist. Visual information is accompanied by optional audio signals. Numerical values and the numerical scale shown in the APICAL ZOOM do not represent actual distance from the apex in mm; they serve as a convenient reference to judge the file tip position in relation to the apex. Operation of BINGO PRO is fully automatic, no manual calibrations or adjustments are required. The measured signal is analyzed and automatic adjustments are made if required. The device may operate within different conditions in the root canal: dry or wet. BINGO PRO may only be used with stainless steel or nickel titanium endodontic files. According to the modern approach, the final distance of the probe tip from the apex should vary in different cases: for example, in non-contaminated root canal the tip should be about 0.5 mm before the minor apical foramen; in case of bacterial contamination the canal should be cleaned to the apex. Such cases may occur in different teeth of the same patient or even in the different canals of the same root. VIRTUAL APEX feature implemented in BINGO PRO enables to mark a predetermined indication position on the display in the APICAL ZOOM area. When VIRTUAL APEX feature is enabled, the dentist gets clear visual and audio feedback that the color bar indicating file tip position has reached the pre-selected point in the apical zone. If the virtual apex is set at the fifth bar, for example, the visual mark appears at 0.5 position. Additionally, special easily recognizable "VIRTUAL APEX" audio signal is activated when the color bar indicator reaches the virtual apex mark. Utilizing the VIRTUAL APEX feature, the dentist may choose to proceed either to the VIRTUAL APEX mark in non-contaminated canals or to the APEX indication in contaminated canals using visual or audio feedback. Numerical value of virtual apex mark does not represent actual distance from the apex in mm. Built-in Demo mode of BINGO PRO enables easy simulation of all stages of the treatment and is designed to simplify familiarization of the user with the device.
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