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510(k) Data Aggregation

    K Number
    K031106
    Device Name
    IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX, MOB-22, MSH-XX
    Manufacturer
    IMTEC CORP.
    Date Cleared
    2003-08-12

    (126 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K063364,K070483,K070601,K080115,K081653,K083544,K083869,K083886,K090049,K092674,K100902,K100932,K111162,K112758,K121707,K131701,K132125,K132178,K133327,K141450,K153173,K162867,K191895
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MDI and MDI PLUS are self-tapping titanium threaded screws indicated for long-term intra-bony applications. Additionally, the MDI may also be used for inter-radicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full partial endentulism, and employing minimally invasive surgical intervention.

    Device Description

    self-tapping titanium threaded screws

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the "IMTEC Sendax MDI and MDI PLUS" dental implants. This document does not contain information about acceptance criteria, study methodologies, or performance metrics for an AI/CADe device.

    Therefore, I cannot provide the requested information. The text is a regulatory clearance document, not a scientific study report.

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