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510(k) Data Aggregation

    K Number
    K211158
    Device Name
    NTI ClenchGuard
    Manufacturer
    Boyd Research, Inc.
    Date Cleared
    2021-09-17

    (151 days)

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

    Boyd Research, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. As an aid in the reduction of medically diagnosed migraine pain associated with jaw clenching and bruxing; 2. Protection against bruxism or nighttime teeth grinding and reduce damage and the noise associated with bruxing and/or grinding.
    Device Description
    Not Found
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    K Number
    K181005
    Device Name
    ClenchGuard
    Manufacturer
    Boyd Research, Inc.
    Date Cleared
    2020-01-15

    (639 days)

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

    Boyd Research, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Protection against bruxism or nighttime teeth grinding. - Reduce damage to the teeth and reduce the noise associated with bruxing and/or grinding.
    Device Description
    Not Found
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