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

    DESENS-IONOMER

    K Number: K032175 · Decision Oct 9, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    144
    Registration Numbers
    144
    Same Product Code
    504
    Applicant Total
    7
    Review Days
    85

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    Basic Information

    Device Name
    DESENS-IONOMER
    K Number
    K032175
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3275
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Milton Hodosh, M.D.
    Date Received
    July 16, 2003
    Decision Date
    October 9, 2003
    Product Code
    EMA
    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
    EMA Cement, Dental

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    Other Clearances by Milton Hodosh, M.D.

    K Number Device Name
    K031721 COMPOSITE RESTORATION MATERIAL
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    K925207 GLASS IONOMER CEMENT
    K905582 POTASSIUM NITRATE COMPOSITE RESTORATION PIT AND
    K895988 POTASSIUM NITRATE-ZINC OXIDE EUGENOL TEMP. DENTAL
    K882417 POTASSIUM NITRATE POLYCARBOXYLATE DENTAL CEMENT