BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    Mouth Guard (ATG0603R)

    K Number: K231865 · Decision Nov 6, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    44
    Applicant Total
    1
    Review Days
    133

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    Basic Information

    Device Name
    Mouth Guard (ATG0603R)
    K Number
    K231865
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Reazeal Corp
    Date Received
    June 26, 2023
    Decision Date
    November 6, 2023
    Product Code
    OBR
    Advisory Committee
    Unknown
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OBR Mouthguard, Over-The-Counter

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