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

    ALPHA-DENT ZINC OXIDE EUGENOL TEMPORARY CEMENT

    K Number: K955089 · Decision Dec 13, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    144
    Registration Numbers
    144
    Same Product Code
    504
    Applicant Total
    32
    Review Days
    36

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    Basic Information

    Device Name
    ALPHA-DENT ZINC OXIDE EUGENOL TEMPORARY CEMENT
    K Number
    K955089
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3275
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Wallace A. Erickson & Co.
    Date Received
    November 7, 1995
    Decision Date
    December 13, 1995
    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 Wallace A. Erickson & Co.

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    K960122 ALPHA-DENT TEMPORARY CROWN AND BRIDGE MATERIAL
    K955521 ALPHA-DENT COPAL CAVITY VARNISH
    K942742 ALPHA BOND-RITE II(TM) OR BOND-RITE II(TM) 2-PASTE ADHEV
    K942727 ALPHA BOUND-RITE I NO-MIX ADHESIVE OR BOND-RITE I NO-MIX ADHESIVE
    K935625 ALPHADENT LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM WITH FLUORIDE
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