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510(k) Data Aggregation

    K Number
    K141970
    Device Name
    DIGITEK TITANIUM ABUTMENT
    Date Cleared
    2015-07-31

    (375 days)

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

    DIGITEK DENTAL SOLUTIONS LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Digitek Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the ASTRA TECH Implant System OsseoSpeed™ 3.5mm, 4.0mm, 4.5mm, 5.0mm implants.
    Device Description
    Digitek Titanium Abutments are endosseous implant abutments which are placed into a corresponding dental implant to provide support for a prosthetic restoration. These abutments are made of titanium grade Ti-6AI-4V ELI (meets ASTM Standard F136). The abutment is mounted into the implant with a screw. These abutments are compatible with the ASTRA TECH Implant System OsseoSpeed™ implants. Digitek Titanium Abutments are provided straight only and are not intended to be modified to provide an angle correction. Digitek Titanium Abutments are manufactured in two models "3.5" and "4.0". And a hexagonal prism at the base of the Digitek Titanium Abutments acts as an anti-rotation feature. Digitek titanium Abutments are supplied in a non-sterile state and should be sterilized prior to installation.
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