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510(k) Data Aggregation

    K Number
    K200827
    Device Name
    LOCATOR R-Tx
    Manufacturer
    Ivory Super Holdco, Incp.
    Date Cleared
    2020-09-02

    (156 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ivory Super Holdco, Incp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LOCATOR R-Tx® Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. The LOCATOR R-Tx Attachment System is compatible with the following implant systems: (list of compatible implant systems and diameters follows).
    Device Description
    LOCATOR R-Tx implant attachment system, consists of abutments, nylon or PEEK liners and denture caps to serve in a similar function to LOCATOR as a resilient attachment for endosseous implants. All LOCATOR R-Tx abutments are made of titanium alloy and have the same coronal double ridge retention design that attaches to the overdenture component. The threaded apical end of the abutment connects to the implant and is specific to each compatible implant system and diameter. LOCATOR R-Tx is designed to accommodate a path of insertion on implants that are divergent up to 30° unless prohibited by the implant manufacturer. LOCATOR R-Tx abutments are provided with either TiCN or TiN coating and available in six cuff heights (1, 2, 3, 4, 5, and 6 mm). The abutments are provided in diameters 3.0 - 6.5 mm as shown below in the compatibility table.
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