BEUDAMED
    Product Code: NSL FDA not classified

    Dentures, Full

    Unknown

    Full Dentures are foreign dental laboratory manufactured complete prosthetic dental devices made from denture resins, designed to replace all teeth in a dental arch and restore full mouth function and aesthetics. They are indicated for edentulous patients who have lost all teeth in one or both dental arches. The product code is NSL, reviewed by the Dental panel, and carries an FDA Not Classified (N) designation with unclassified reason code 6 for foreign manufacturing. No regulation number is assigned, and the device carries no implant or life-sustaining support flags.

    View on FDA
    510(k)s
    0
    FEI Numbers
    161
    Registration Numbers
    161
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    NSL
    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

    Foreign dental lab manufactured full dentures are manufactured as finished products from denture resins.

    Unclassified Reason

    6

    FEI Numbers

    This FDA classification entry is associated with 161 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 161 registration numbers. Click on an entry to view related FDA registrations.