BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    COMPLETE DENTURE REPAIR KIT

    K Number: K850927 · Decision Jul 2, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    119

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    Basic Information

    Device Name
    COMPLETE DENTURE REPAIR KIT
    K Number
    K850927
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3570
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Tooth Aid Lab, Inc.
    Date Received
    March 5, 1985
    Decision Date
    July 2, 1985
    Product Code
    EBO
    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
    EBO Denture Repair Kit

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