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510(k) Data Aggregation

    K Number
    K243801
    Device Name
    FRONT-LINE Field Sterilizer (FL135)
    Manufacturer
    Fort Defiance Industries LLC
    Date Cleared
    2025-03-07

    (86 days)

    Product Code
    FLE
    Regulation Number
    880.6880
    Why did this record match?
    Applicant Name (Manufacturer) :

    Fort Defiance Industries LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fort Defiance Industries FRONT-LINE Field Sterilizer (FL135) is an autoclave designed for sterilizing heat- and moisture-stable medical, dental, and surgical materials, including wrapped, solid, porous, and hollow items (e.g., dental handpieces, suction pipes) in healthcare facilities.
    Device Description
    The Fort Defiance Industries FRONT-LINE Field Sterilizer, model FL135, is an autoclave designed for sterilizing heat- and moisture-stable medical, dental, and surgical materials, including wrapped and unwrapped, solid, porous, and hollow items (e.g., dental handpieces, suction pipes) in healthcare facilities. The device uses electrical resistive heaters to produce steam as the sterilizing agent. The device adheres to sterilization processes and requirements that are universally accepted sterilization standards for Tabletop Steam Sterilizers. A touchscreen controller is used for monitoring and control of the device.
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    K Number
    K213457
    Device Name
    Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135
    Manufacturer
    Fort Defiance Industries LLC
    Date Cleared
    2022-03-02

    (126 days)

    Product Code
    FLE
    Regulation Number
    880.6880
    Why did this record match?
    Applicant Name (Manufacturer) :

    Fort Defiance Industries LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fort Defiance Industries FRONT-LINE Field Sterilizers are autoclaves designed for sterilizing heat- and moisturestable medical, dental, and surgical materials, including wrapped, solid, porous, and hollow items (e.g., dental handpieces, suction pipes) in healthcare facilities.
    Device Description
    The Fort Defiance Industries FRONT-LINE Field Sterilizers are autoclaves designed for sterilizing heat- and moisture-stable medical, dental, and surgical materials, including wrapped and unwrapped, solid, porous, and hollow items (e.g., dental handpieces, suction pipes) in healthcare facilities. The devices use electrical resistive heaters to produce steam as the sterilizing agent. The devices adhere to sterilization processes and requirements that are universally accepted sterilization standards for Tabletop Steam Sterilizers. A touchscreen controller is used for monitoring and control of the device. The devices are equipped with multiple safety features. The door includes a safety locking mechanism and door switch. The door switch does not permit cycle operation unless the door is sealed closed and does not permit the door to be opened until the internal chamber pressure is at atmospheric pressure. Additional safety features include electronic overtemperature and overpressure protection, an independent high temperature cutoff switch, and a pressure safety relief valve for the pressure vessel. Only United States Food and Drug Administration cleared sterilization accessories should be used with these autoclaves.
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