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

    FLARE,FILE, FILL

    K Number: K981234 · Decision Jun 5, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    261
    Registration Numbers
    261
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    62

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    Basic Information

    Device Name
    FLARE,FILE, FILL
    K Number
    K981234
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Lone Star Technologies
    Date Received
    April 4, 1998
    Decision Date
    June 5, 1998
    Product Code
    EJB
    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
    EJB Handle, Instrument, Dental

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