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

    enCore Night Guard

    K Number: K252004 · Decision Nov 25, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    44
    Applicant Total
    2
    Review Days
    151

    Basic Information

    Device Name
    enCore Night Guard
    K Number
    K252004
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Encore Guards
    Date Received
    June 27, 2025
    Decision Date
    November 25, 2025
    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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    Other Clearances by Encore Guards

    K Number Device Name
    K251926 enCore Impression Material