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

    STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR

    K Number: K863500 · Decision Sep 22, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    18
    Applicant Total
    5
    Review Days
    13

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    Basic Information

    Device Name
    STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR
    K Number
    K863500
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Pacific Union Dental, Inc.
    Date Received
    September 9, 1986
    Decision Date
    September 22, 1986
    Product Code
    EIS
    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
    EIS Remover, Crown

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