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510(k) Data Aggregation

    K Number
    K133037
    Device Name
    GRINDGUARD
    Manufacturer
    GRIND GUARD TECHNOLOGIES, LLC
    Date Cleared
    2014-01-23

    (119 days)

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

    GRIND GUARD TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GrindGuardN is a mouth guard intended to protect against grinding and clenching.
    Device Description
    The GrindGuard® is an oral appliance consisting of a thin exterior tray (shell) that covers approximately half of the lower or upper arch, with a dome shape protrusion (in the center of the device), to be situated over the central incisors and an internal layer which can be melted at low temperatures and molded to the individuals' teeth. The outer tray is manufactured from polysulfone material and is formed by injection molding. The inner, formable layer consists of polycaprolactone. The GrindGuard® is designed to prevent night grinding. After a brief submersion in water which has been heated in the microwave the thermoplastic liner becomes translucent and formable. The patient centers the device over his/her lower front teeth and bites until pressure is felt on upper and lower two front teeth. Gentle pressure is applied to the ends of the GrindGuard4 for approximately 2 minutes in order to set the thermoplastic material. The rigid polysulfone outer tray helps the softer material maintain shape and conformity with the teeth while forming the device.
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    K Number
    K082723
    Device Name
    GRINDGUARD
    Manufacturer
    GRIND GUARD TECHNOLOGIES, LLC
    Date Cleared
    2009-08-31

    (348 days)

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

    GRIND GUARD TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GrindGUARDN is a mouth guard intended to protect against grinding and clenching.
    Device Description
    The GrinGUARDN is an oral appliance consisting of a rigid outer tray with a dome shape protrusion in the center of the tray, to be situated over the lower incisors and an internal layer, which can be melted at low temperatures and molded to the individuals' teeth. The outer tray is manufactured from polysulfone material and the inner, moldable layer consists of polycaprolactone.
    Ask a Question

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