BEUDAMED
    Product Code: EMH FDA class 1 21 CFR 872.4565

    Forceps, Rongeur, Surgical

    Dental

    The surgical rongeur forceps is a dental instrument designed for biting away small pieces of bone or tissue, commonly used during oral surgical procedures such as tooth extractions or jaw surgeries. It is classified as FDA Class 1, indicating the lowest risk category subject to general controls only. The product code is EMH, regulated under 21 CFR 872.4565 in the Dental specialty. No special regulatory flags apply to this device.

    View on FDA
    510(k)s
    8
    FEI Numbers
    164
    Registration Numbers
    164
    Unique Applicants
    7
    Years Active
    11

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    Basic Information

    Product Code
    EMH
    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
    K890256 BONE RONGEUR, DOUBLE-ACTION
    K890255 BONE RONGEUR, SINGLE-ACTION
    K854887 MANU/SURG INST/ACCESS WUERZBURG TIT MINI BONE PLAT
    K851710 586 TO 596 VARIOUS TYPES DENTAL ROOT SPLINTER FORC
    K834190 JAKOBI SURG. INSTRUMENTS #8 15
    K834366 SURGICAL INSTRUMENTS & ACCESSORIES
    K821358 MODIFIED RONGEURS FOR SPINAL & ORTH. S.
    K771522 FORCEPS, STYLE #849

    FEI Numbers

    This FDA classification entry is associated with 164 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 164 registration numbers. Click on an entry to view related FDA registrations.