BEUDAMED
    Product Code: EJZ FDA class 1 21 CFR 872.4565

    Knife, Margin Finishing, Operative

    Dental

    The Operative Margin Finishing Knife is a hand instrument with a sharp, beveled blade used to refine and smooth the margins and walls of prepared cavities, ensuring an accurate fit for restorations and minimizing microleakage at the restoration-tooth interface. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EJZ, regulated under 21 CFR 872.4565 in the Dental (DE) specialty.

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    510(k)s
    2
    FEI Numbers
    37
    Registration Numbers
    37
    Unique Applicants
    2
    Years Active
    5

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    Basic Information

    Product Code
    EJZ
    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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K872622 ORTHODONTIC ARCH
    K823315 DENTAL INSTRUMENTS - KNIVES

    FEI Numbers

    This FDA classification entry is associated with 37 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 37 registration numbers. Click on an entry to view related FDA registrations.