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510(k) Data Aggregation

    K Number
    K082301
    Device Name
    GRIND NO MORE
    Manufacturer
    PLACONTROL INC.
    Date Cleared
    2008-10-06

    (55 days)

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

    PLACONTROL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Grind No More is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or teeth grinding.
    Device Description
    Grind No More is a posterior-only occlusive mouthguard, consisting of two molar bite plates connected by a buccal retention band.
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