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

    TEMPOARY POLYCARBONATE CROWNS

    K Number: K932759 · Decision Jul 22, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    8
    Applicant Total
    1
    Review Days
    409

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    Basic Information

    Device Name
    TEMPOARY POLYCARBONATE CROWNS
    K Number
    K932759
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3330
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    South American Dental Exporting Corp.
    Date Received
    June 8, 1993
    Decision Date
    July 22, 1994
    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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