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

    DE-BOND 200

    K Number: K883418 · Decision Oct 24, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    30
    Applicant Total
    1
    Review Days
    435

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    Basic Information

    Device Name
    DE-BOND 200
    K Number
    K883418
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Scheu-Dental
    Date Received
    August 15, 1988
    Decision Date
    October 24, 1989
    Product Code
    EKS
    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
    EKS File, Pulp Canal, Endodontic

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