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

    ASEPTYLUM, UNI-CARRIER

    K Number: K961714 · Decision Jun 10, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    99
    Registration Numbers
    99
    Same Product Code
    71
    Applicant Total
    1
    Review Days
    39

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    Basic Information

    Device Name
    ASEPTYLUM, UNI-CARRIER
    K Number
    K961714
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Distriflor S.A.
    Date Received
    May 2, 1996
    Decision Date
    June 10, 1996
    Product Code
    EKJ
    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
    EKJ Burnisher, Operative

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