BEUDAMED
    Product Code: EKN FDA class 1 21 CFR 872.3830

    Point, Paper, Endodontic

    Dental

    The Endodontic Paper Point is a precisely tapered absorbent paper cone used to dry the root canal space after irrigation prior to obturation, ensuring no residual moisture remains that could compromise the seal of the filling material. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EKN, regulated under 21 CFR 872.3830 in the Dental (DE) specialty.

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    510(k)s
    7
    FEI Numbers
    83
    Registration Numbers
    83
    Unique Applicants
    6
    Years Active
    8

    Basic Information

    Product Code
    EKN
    Device Class
    FDA class 1
    Regulation Number
    872.3830
    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 7 510(k) clearances via K numbers.

    K Number Device Name
    K843017 ABSORBENT ENDODONTIC POINT
    K821625 ENDODONTIC PAPERPOINTS
    K812886 ENDODONTIC PAPER POINTS
    K800827 PREMIER ABSORBENT POINTS
    K781605 R&R ABSORBENT POINTS
    K761203 ABSORBENT POINTS
    K760983 ENDODONTIC INSTRUMENTS

    FEI Numbers

    This FDA classification entry is associated with 83 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 83 registration numbers. Click on an entry to view related FDA registrations.