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510(k) Data Aggregation

    K Number
    K052823
    Device Name
    IMPLANTIUM ABUTMENTS
    Manufacturer
    DENTIUM, INC.
    Date Cleared
    2006-02-21

    (140 days)

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

    DENTIUM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Implantium abutments are intended to be used with the Implantium root-form endosseous dental implant to aid in prosthetic rehabilitation including overdenture retention. After the root-form endosseous dental implant is surgically placed, the endosseous dental implant abutment device is attached to it.
    Device Description
    The Implantium abutments are devices made of pure titanium, titanium alloys, and plastic. The abutments in this 510(k) submission are supplemental to the previously cleared Implantium devices (K041368) and are designed to be used with the Implantium fixtures. These abutments are placed in the fixtures as a support for fitting prosthetic teeth. This submission includes four differently sized ball abutment kits for overdenture retention, and six different temporary abutments for placement of temporary restorations.
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