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

    DENTURE-TIGHT

    K Number: K790589 · Decision Aug 10, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    2
    Applicant Total
    29
    Review Days
    136

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    Basic Information

    Device Name
    DENTURE-TIGHT
    K Number
    K790589
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3560
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Den-Mat Corp.
    Date Received
    March 27, 1979
    Decision Date
    August 10, 1979
    Product Code
    EBP
    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
    EBP Reliner, Denture, Over The Counter

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