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

    HYGIENIC RUBBER DAM FRAME

    K Number: K780746 · Decision May 12, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    2
    Applicant Total
    6
    Review Days
    29

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    Basic Information

    Device Name
    HYGIENIC RUBBER DAM FRAME
    K Number
    K780746
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6300
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Hygienic Dental Mfg., Co., The
    Date Received
    April 13, 1978
    Decision Date
    May 12, 1978
    Product Code
    EJE
    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
    EJE Frame, Rubber Dam

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    Other Clearances by Hygienic Dental Mfg., Co., The

    K Number Device Name
    K780804 HYGIENIC ANCHORINGS
    K780745 RUBBER DAM
    K780743 CLAMP FORCEPS
    K780744 BRINKER TISSUE RETRACTORS
    K770117 HYGIENIC 5 & 6 RUBBER DAM FRAME