BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    CORRECT DENTAL IMPRESSION MATERIAL

    K Number: K042860 · Decision Dec 3, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    401
    Applicant Total
    1
    Review Days
    49

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    Basic Information

    Device Name
    CORRECT DENTAL IMPRESSION MATERIAL
    K Number
    K042860
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Handae Chemical Co., Ltd.
    Date Received
    October 15, 2004
    Decision Date
    December 3, 2004
    Product Code
    ELW
    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
    ELW Material, Impression

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