LogoFDA 510(k) Search
Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K970572
    Device Name
    DUAL INTEGRATOR DENTAL IMPLANT ACCESSORIES PARALLEL PIN, DEPTH GAGE, AND SURGICAL RATCHET
    Manufacturer
    IMPLANT INTEGRATION SYSTEMS, INC.
    Date Cleared
    1998-01-16

    (336 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMPLANT INTEGRATION SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is designed for use in the placement of the "Dual Integrator" Dental Implant (K944225). The Parallel Pin is used to insure correct vertical placement of the implant. The Depth Gauge is used to measure the depth of surgical site, while the Surgical Ratchet is used to screw the "Dual Integrator" Dental Implant into the surgical site. These products along with the "Dual Integrator" Dental Implant make up the total system of tooth replacement by Implant Integration Systems.
    Device Description
    The "Dual Integrator" Parallel Pin, Depth Gage, and Surgical Ratchet are all intended to be used with the Implant Integration Systems "Dual Integrator" Dental Implant (K944225).
    Ask a Question
    K Number
    K962610
    Device Name
    DUAL INTEGRATOR DENTAL IMPLANT ACCESSORIES
    Manufacturer
    IMPLANT INTEGRATION SYSTEMS, INC.
    Date Cleared
    1996-10-18

    (107 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMPLANT INTEGRATION SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The "Dual Integrator" Healing Cap, Implant Carrier Assembly, and Activator Pin Driver are all intended to be used with the Implant Integration Systems "Dual Integrator" Dental Implant (K944225).
    Device Description
    Not Found
    Ask a Question
    K Number
    K962394
    Device Name
    IMPLANT INTEGRATION SYSTEMS DRILLS AND TAPS
    Manufacturer
    IMPLANT INTEGRATION SYSTEMS, INC.
    Date Cleared
    1996-10-11

    (113 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMPLANT INTEGRATION SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Implant Integration Systems Surgical Drills are intended to be used in the placement of the "Dual Integrator" Dental Implant (K944225).
    Device Description
    This product is similar in design, composition (titanium nitrade coated stainless steel) and function to the Implant Innovations, Inc. Surgical Drills (K891615), the Impla-Med Corp. Titanium/Stainless Steel Dental Implant Drills (K902158) and the Steri-oss Drills and Taps (K915733).
    Ask a Question

    Page 1 of 1