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

    ROEKO CALCIUM HYDROXIDE POINTS

    K Number: K973539 · Decision Oct 30, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    76
    Applicant Total
    1
    Review Days
    42

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    Basic Information

    Device Name
    ROEKO CALCIUM HYDROXIDE POINTS
    K Number
    K973539
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3250
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roeko USA, Inc.
    Date Received
    September 18, 1997
    Decision Date
    October 30, 1997
    Product Code
    EJK
    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
    EJK Liner, Cavity, Calcium Hydroxide

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