BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ENDODONTIC PAPERPOINTS

    K Number: K821625 · Decision Jun 14, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    12

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    Basic Information

    Device Name
    ENDODONTIC PAPERPOINTS
    K Number
    K821625
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3830
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Roeko
    Date Received
    June 2, 1982
    Decision Date
    June 14, 1982
    Product Code
    EKN
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EKN Point, Paper, Endodontic

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