BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CERAMIC PEDATRIC PREFORMED CROWN

    K Number: K091362 · Decision Jun 29, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    8
    Applicant Total
    1
    Review Days
    52

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    Basic Information

    Device Name
    CERAMIC PEDATRIC PREFORMED CROWN
    K Number
    K091362
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3330
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ez-Pedo, Inc.
    Date Received
    May 8, 2009
    Decision Date
    June 29, 2009
    Product Code
    ELZ
    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
    ELZ Crown, Preformed

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