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

    DISTAFLEX

    K Number: K823280 · Decision Nov 22, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    23
    Applicant Total
    1
    Review Days
    19

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    Basic Information

    Device Name
    DISTAFLEX
    K Number
    K823280
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3165
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Duradent Corp.
    Date Received
    November 3, 1982
    Decision Date
    November 22, 1982
    Product Code
    EGG
    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
    EGG Attachment, Precision, All

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