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

    MIS LOCKiT Abutments System, OT-Equators and Ball Attachments

    K Number: K182228 · Decision Jan 28, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    382
    Registration Numbers
    382
    Same Product Code
    708
    Applicant Total
    13
    Review Days
    165

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    Basic Information

    Device Name
    MIS LOCKiT Abutments System, OT-Equators and Ball Attachments
    K Number
    K182228
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3630
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mis Implants Technologies , Ltd.
    Date Received
    August 16, 2018
    Decision Date
    January 28, 2019
    Product Code
    NHA
    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
    NHA Abutment, Implant, Dental, Endosseous

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