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

    ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT)

    K Number: K933543 · Decision Nov 1, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    144
    Registration Numbers
    144
    Same Product Code
    504
    Applicant Total
    8
    Review Days
    104

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    Basic Information

    Device Name
    ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT)
    K Number
    K933543
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3275
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Jedental Co., Inc.
    Date Received
    July 20, 1993
    Decision Date
    November 1, 1993
    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 Jedental Co., Inc.

    K Number Device Name
    K933612 JEDENTAL;PCA CEMENT (POLYCARBOXYLATE CEMENT)
    K935718 JEDENTAL VLC DENTAL CURING LIGHT
    K934073 JEDENTAL GLASS IONOMER CEMENT AND LINER
    K935727 P&FS PIT AND FISSURE SEALANT
    K933656 JEDENTAL PSROFILL SELF-CURE COMPOSITE
    K933554 JEDENTAL ZINC CEMENT IMPROVED
    K931880 PROFILL LC COMPOSITE