BEUDAMED
    Product Code: EMP FDA class 1 21 CFR 872.4565

    Marker, Periodontic

    Dental

    The periodontic marker is a dental instrument used to transfer measurements or mark tissue prior to incision during periodontal surgical procedures. It is classified as FDA Class 1, subject only to general controls and exempt from premarket notification requirements. The product code is EMP, regulated under 21 CFR 872.4565 in the Dental specialty. No special regulatory flags apply.

    View on FDA
    510(k)s
    0
    FEI Numbers
    23
    Registration Numbers
    23
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    EMP
    Device Class
    FDA class 1
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    4

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 23 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 23 registration numbers. Click on an entry to view related FDA registrations.