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

    DUAL INTEGRATOR DENTAL IMPLANT

    K Number: K944225 · Decision Sep 27, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    4
    Review Days
    393

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    Basic Information

    Device Name
    DUAL INTEGRATOR DENTAL IMPLANT
    K Number
    K944225
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Implant Integration Systems, Inc.
    Date Received
    August 30, 1994
    Decision Date
    September 27, 1995
    Product Code
    DZE
    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
    DZE Implant, Endosseous, Root-Form

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    Other Clearances by Implant Integration Systems, Inc.

    K Number Device Name
    K970572 DUAL INTEGRATOR DENTAL IMPLANT ACCESSORIES PARALLEL PIN, DEPTH GAGE, AND SURGICAL RATCHET
    K962610 DUAL INTEGRATOR DENTAL IMPLANT ACCESSORIES
    K962394 IMPLANT INTEGRATION SYSTEMS DRILLS AND TAPS