BEUDAMED
    Product Code: EJB FDA class 1 21 CFR 872.4565

    Handle, Instrument, Dental

    Dental

    The Dental Instrument Handle is a reusable grip component onto which interchangeable working tips or blades are attached, allowing dental clinicians to configure a variety of hand instruments such as scalers, explorers, and carvers using a single ergonomic handle. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EJB, regulated under 21 CFR 872.4565 in the Dental (DE) specialty.

    View on FDA
    510(k)s
    8
    FEI Numbers
    261
    Registration Numbers
    261
    Unique Applicants
    8
    Years Active
    31

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    Basic Information

    Product Code
    EJB
    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 8 510(k) clearances via K numbers.

    K Number Device Name
    K140144 BENDA WEDGE
    K023367 DETECTAR, MODEL N123-MI
    K981234 FLARE,FILE, FILL
    K930094 AUKUSLEEVE
    K922633 CAVI-ZYME
    K871818 SPATULA, DENTAL, CEMENT
    K833338 TOOTH SLOOTH
    K823913 SOFT GRIP UNI-HANDLE

    FEI Numbers

    This FDA classification entry is associated with 261 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 261 registration numbers. Click on an entry to view related FDA registrations.