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

    KIS MT3

    K Number: K960110 · Decision Mar 20, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    12
    Review Days
    69

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    Basic Information

    Device Name
    KIS MT3
    K Number
    K960110
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Implant Center of the Palm Beaches
    Date Received
    January 11, 1996
    Decision Date
    March 20, 1996
    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 The Implant Center of the Palm Beaches

    K Number Device Name
    K974280 ABUTMENT - COMPLETE
    K960111 KIS MT4
    K960112 KIS MT5
    K955048 KIS MED THREAD IMPLANT & PROSTHESIS SYSTEM
    K953558 KIS II LG HEX SCREW & CYLINDER IMPLANTS
    K953234 SCREW IMPLANTS, GRADE 3; UNCOATED, HA, TP-B3
    K954539 LG HEX PROSTHETICS
    K953237 PROSTHETICS & INSTRUMENTATION A. PROSTHETIC ABUTMENTS 4, 5, 6 DIAMETER, GRADE 3, B. IRRIGATION DRILLS, TOOLING & PREANG'
    K953235 SCREW IMPLANTS, GRADE 3; UNCOATED, HA, TP-K3
    K953236 CYLINDER IMPLANTS HA, TP, GRADE 3
    Search all 12 clearances from The Implant Center of the Palm Beaches →