BEUDAMED
    Product Code: EKB FDA class 1 21 CFR 872.4565

    Explorer, Operative

    Dental

    The Operative Explorer is a dental hand instrument with a sharp, thin wire tip used to detect caries, assess surface textures of teeth and restorations, locate calculus deposits, and probe restorative margins for defects during clinical examination. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EKB, regulated under 21 CFR 872.4565 in the Dental (DE) specialty.

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    510(k)s
    3
    FEI Numbers
    138
    Registration Numbers
    138
    Unique Applicants
    3
    Years Active
    3

    Basic Information

    Product Code
    EKB
    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 3 510(k) clearances via K numbers.

    K Number Device Name
    K851724 1410/1 TO 1435/13 VARIOUS PROBES & EXPLORERS
    K823914 EXPLORER TIP
    K821780 BEACH EXPLORER NO. 23T.G.

    FEI Numbers

    This FDA classification entry is associated with 138 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 138 registration numbers. Click on an entry to view related FDA registrations.