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

    DREAM DAM

    K Number: K875255 · Decision Mar 18, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    110
    Registration Numbers
    110
    Same Product Code
    32
    Applicant Total
    2
    Review Days
    87

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    Basic Information

    Device Name
    DREAM DAM
    K Number
    K875255
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6300
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Dental Dam, Inc.
    Date Received
    December 22, 1987
    Decision Date
    March 18, 1988
    Product Code
    EIE
    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
    EIE Dam, Rubber

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    Other Clearances by Dental Dam, Inc.

    K Number Device Name
    K864096 DREAM DAM