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

    PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT

    K Number: K112574 · Decision Jan 23, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    142
    Registration Numbers
    142
    Same Product Code
    495
    Applicant Total
    9
    Review Days
    139

    Basic Information

    Device Name
    PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT
    K Number
    K112574
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3275
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    PRIME DENTAL MANUFACTURING, INC.
    Date Received
    September 6, 2011
    Decision Date
    January 23, 2012
    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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