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

    NIGHTGUARD DIAGNOSTIC APPLIANCE

    K Number: K955701 · Decision Mar 8, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    70
    Applicant Total
    2
    Review Days
    84

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    Basic Information

    Device Name
    NIGHTGUARD DIAGNOSTIC APPLIANCE
    K Number
    K955701
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cycura Corp.
    Date Received
    December 15, 1995
    Decision Date
    March 8, 1996
    Product Code
    MQC
    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
    MQC Mouthguard, Prescription

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    Other Clearances by Cycura Corp.

    K Number Device Name
    K953257 ORALSENSOR