BEUDAMED
    Product Code: EJY FDA class 1 21 CFR 872.4565

    Pliers, Operative

    Dental

    Operative Dental Pliers are hinged hand instruments used in restorative and prosthetic dentistry to grip, bend, contour, and place matrix bands, metal strips, and other restorative materials or components during operative procedures. They are classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EJY, regulated under 21 CFR 872.4565 in the Dental (DE) specialty.

    View on FDA
    510(k)s
    2
    FEI Numbers
    105
    Registration Numbers
    105
    Unique Applicants
    2
    Years Active
    3

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    Basic Information

    Product Code
    EJY
    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
    K851730 2710 TO 2935 VARIOUS PLIERS FOR ORTHODONTICS/PROST
    K821787 BEACH SURGICAL PLIERS NON-HOOK

    FEI Numbers

    This FDA classification entry is associated with 105 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 105 registration numbers. Click on an entry to view related FDA registrations.