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510(k) Data Aggregation

    K Number
    K152845
    Device Name
    Allied Biocompat Abutment for Nobel Replace Interface
    Manufacturer
    ALLIED DENTAL SOLUTIONS
    Date Cleared
    2016-03-14

    (167 days)

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

    ALLIED DENTAL SOLUTIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Allied Biocompat abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prostheses in the mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment screw is intended to secure the Allied Dental Solutions abutment to the endosseous implant. Allied Biocompat Abutments are compatible with the following Implant Manufacturer: Nobel Biocare Implant Line: Replace Select Straight and Select Straight One Stage, Replace Select Tapered one Stage Implant Diameters: 3.5 (NP), 4.0 (RP), 5.0 (WP) and 6.0
    Device Description
    Allied Biocompat patient-specific abutments are made from Ti-6Al-4V ELI which meets ASTM F136. Two abutment screw designs are included because the standard one does not fit the narrowest platform. The abutment is placed over the shoulder of the implant and fastened with the appropriate abutment screw. The patient-specific abutments designs share the same internal tri-lobe prosthetic interface but there are different implant platform diameters so there are 4 different diameters of abutment. The maximum angulation which can be ordered is 25°. Allied Biocompat NB internal tri-lobe 3.5mm Allied Biocompat NB internal tri-lobe 4.0mm Allied Biocompat NB internal tri-lobe 5.0mm Allied Biocompat NB internal tri-lobe 6.0mm These are patient-specific CAD/CAM abutments designed and fabricated under the manufacturing control of Allied Dental Solutions.
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