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510(k) Data Aggregation

    K Number
    K222845
    Device Name
    Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece
    Date Cleared
    2023-11-28

    (433 days)

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

    Frey Oral Technologies LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Clench Relief Mouth Piece PRO RX is indicated for protection of teeth and restorations from injury due to teeth grinding, bruxism, and jaw clenching; temporary relief of TMD and bruxism by reducing muscle tension, and temporary treatment of TMD along with the relief of associated headaches and pains.
    Device Description
    The Clench Relief Mouth Piece PRO RX is a custom-fit temporary mouthguard which allows the user to achieve a jaw position that alleviates clenching, grinding, and bruxism and help diminish TMD type muscle pain symptoms along with jaw clicking and popping. It allows the prescriber to set and create a new bite plane for the patient that allows the lower jaw to come down and forward from its habitual bite position thus freeing it from its habitual muscle tension. The mouthguard kits contain the Clench Relief Mouthpiece Frame with alignment guide and Clench Relief Fit Material (VPS putty provided as catalyst and base). The mouthpiece frame is packed with mixed putty and placed passively over the lower teeth. The end user must bite on the alignment guide for 2 minutes while the Clench Relief Fit Material sets. Heating of the mouthguard/putty is not required for molding. The mouthpiece frame and alignment guide are manufactured from ethylvinyl acetate (EVA). The putty is manufactured from vinyl polysiloxane (VPS) which was previously cleared under K821221.
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