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

    FOREMOST DENTIN ADHESIVE

    K Number: K864898 · Decision Feb 12, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    144
    Registration Numbers
    144
    Same Product Code
    504
    Applicant Total
    14
    Review Days
    59

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    Basic Information

    Device Name
    FOREMOST DENTIN ADHESIVE
    K Number
    K864898
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3275
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Foremost Dental Mfg., Inc.
    Date Received
    December 15, 1986
    Decision Date
    February 12, 1987
    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 Foremost Dental Mfg., Inc.

    K Number Device Name
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    K981813 PERMACEM AUTOMIX LUTING CEMENT SYSTEM
    K980963 HONIGUM AUTOMIX IMPRESSION MATERIAL (FOIL BAGS) AND HONIGUM QUICK IMPRESSION MATERIAL (CARTRIDGES)
    K970683 ZENTIH FLOWABLE COMPOSITE (MULTIPLE)
    K970774 TEMPOCEM NE (MULTIPLE)
    K970775 TEMPO CEM (MULTIPLE)
    K954867 IONOSIT SEAL
    K935032 ZENITH TOTAL ETCH 10% PHOSPHORIC ACID
    K890464 ZENITH 40% PHOSPHORIC ACID GEL
    K871562 IONOCAL
    Search all 14 clearances from Foremost Dental Mfg., Inc. →