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

    POLYDIMETHYLSILOXANE IMPRESSION MATERIAL

    K Number: K131510 · Decision Dec 20, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    401
    Applicant Total
    1
    Review Days
    210

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    Basic Information

    Device Name
    POLYDIMETHYLSILOXANE IMPRESSION MATERIAL
    K Number
    K131510
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Blackwell Device Consulting
    Date Received
    May 24, 2013
    Decision Date
    December 20, 2013
    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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