BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇱 Chile

    MADEGOM LTDA. DENTAL DAM

    K Number: K894120 · Decision Aug 21, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    110
    Registration Numbers
    110
    Same Product Code
    32
    Applicant Total
    2
    Review Days
    70

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MADEGOM LTDA. DENTAL DAM
    K Number
    K894120
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6300
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Madegom
    Date Received
    June 12, 1989
    Decision Date
    August 21, 1989
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (EIE), ordered by most recent decision date.

    armor LC

    FDA 510(k)
    FDA Class 1 ·Dental

    Triumph Resin Dam

    FDA 510(k)
    FDA Class 1 ·Dental

    BARI-KAD PACKING DEVICE

    FDA 510(k)
    FDA Class 1 ·Dental

    GC TION GINGIVAL PROTECTOR

    FDA 510(k)
    FDA Class 1 ·Dental

    BRITESMILE MASKING CREAM

    FDA 510(k)
    FDA Class 1 ·Dental

    PULPDENT PUTTY DAM

    FDA 510(k)
    FDA Class 1 ·Dental
    View all

    Other Clearances by Madegom

    K Number Device Name
    K894119 MADEGOM LTDA. PENROSE DRAIN TUBING