LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K072968
    Device Name
    STRESSGARD NIGHTGUARD
    Manufacturer
    TOTALGARD CORPORATION
    Date Cleared
    2008-07-01

    (253 days)

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

    TOTALGARD CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Stressgard™ Night Guard is indicated for protection from night-time teeth grinding, clenching and bruxism. It is intended to reduce damage to teeth and to prevent the noise associated with teeth grinding or bruxing.
    Device Description
    The TotalGard™ Stressgard™ Night Guard is composed entirely of a soft, flexible semitransparent FDA compliant material, Monprene® thermoplastic elastomers. As packaged, the Stressgard ™ Night Guard is ready for use by the consumer. If desired, the Stressgard™ Night Guard is easily trimmed by the consumer, however it requires no forming or molding for use.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1