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

    LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00

    K Number: K990212 · Decision Sep 14, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    10
    Applicant Total
    13
    Review Days
    235

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    Basic Information

    Device Name
    LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00
    K Number
    K990212
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4600
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Doctor'S Research Group, Inc.
    Date Received
    January 22, 1999
    Decision Date
    September 14, 1999
    Product Code
    DYX
    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
    DYX Lock, Wire, And Ligature, Intraoral

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