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

    DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY

    K Number: K103346 · Decision Feb 11, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    401
    Applicant Total
    1
    Review Days
    88

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    Basic Information

    Device Name
    DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY
    K Number
    K103346
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sherpa Korea
    Date Received
    November 15, 2010
    Decision Date
    February 11, 2011
    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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