BEUDAMED
    Product Code: NXJ FDA not classified

    Denture, Cosmetic Only

    Unknown

    The Denture, Cosmetic Only (product code NXJ) is an oral appliance intended solely to improve an individual's appearance and is not designed to assist in chewing food. It is not classified by the FDA (Class N / FDA not classified), reviewed by the Dental panel, and has been determined to fall outside the scope of device regulation for functional dental purposes. The device carries no implant or life-sustaining flags.

    View on FDA
    510(k)s
    0
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    NXJ
    Device Class
    FDA not classified
    Medical Specialty
    Unknown
    Review Panel
    DE
    Submission Type
    7

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Intended to improve an individual's appearance only. Not intended to assist in chewing food.

    Unclassified Reason

    6

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.