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

    PERFORMED CROWN (STAINLESS STEEL)

    K Number: K883325 · Decision Sep 16, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    8
    Applicant Total
    1
    Review Days
    42

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    Basic Information

    Device Name
    PERFORMED CROWN (STAINLESS STEEL)
    K Number
    K883325
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3330
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Whitecap Dental Co.
    Date Received
    August 5, 1988
    Decision Date
    September 16, 1988
    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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