BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    CONICAL CONNECTION IMPLANTS

    K Number: K112162 · Decision Aug 8, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    13
    Review Days
    378

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    CONICAL CONNECTION IMPLANTS
    K Number
    K112162
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mis Implants Technologies , Ltd.
    Date Received
    July 27, 2011
    Decision Date
    August 8, 2012
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DZE), ordered by most recent decision date.

    MegaGen Zygoma Dental Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    Dental Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    INOSS System

    FDA 510(k)
    FDA Class 2 ·Dental

    Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant

    FDA 510(k)
    FDA Class 2 ·Dental

    Adin Long Dental Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    ZENEX Implant System_Short (R-System)

    FDA 510(k)
    FDA Class 2 ·Dental
    View all

    Other Clearances by Mis Implants Technologies , Ltd.

    K Number Device Name
    K182228 MIS LOCKiT Abutments System, OT-Equators and Ball Attachments
    K180282 MIS Internal Hex Dental Implant System
    K173326 MIS CONNECT Conical Connection Abutment
    K172505 MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments
    K163349 MIS V3 Conical Connection Dental Implant System­
    K110750 PERIOPATCH
    K101014 BOND BONE
    K092555 UNO NARROW IMPLANT
    K080162 UNO - ONE PIECE SCREW-TYPE DENTAL IMPLANT
    K073461 ORTHO ANCHOR SCREWS
    Search all 13 clearances from Mis Implants Technologies , Ltd. →