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510(k) Data Aggregation

    K Number
    K152188
    Device Name
    QUAD Dental Implants and Prostheses
    Date Cleared
    2016-01-28

    (176 days)

    Product Code
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dentack Impants Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    DenTack QUAD Dental Implants and Prostheses are intended for surgical placement in the maxilla and/or in the mandible to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous jaws utilizing delayed loading or immediate loading when good primary stability is achieved and with appropriate occlusal loading.
    Device Description
    DenTack has developed a range of expandable dental implants made of Titanium to serve the need of patients that require partial or complete tooth restoration. The implant is placed so its apical end is in the trabecular (spongy) bone like any other implant. Once in place, the apical portion of the implant is expanded to achieve increased contact surface area with the surrounding bone. The system also includes various accessories that attach to the implant. All DenTack's implant bodies are made of a combination of Titanium alloy according to ASTM F136 and c.p. titanium according to ASTM F67. Abutments are made of same Titanium alloy while denture components are made of stainless-steel and polymers. DenTack's QUAD Implants are available in outer diameter (OD) of: 3.75 and 4.1 mm. The implants' length dimensions are from 7 to 11 mm. DenTack's Prostheses are identified as follows: Metal housing Plastic cup Straight Multi-unit Sleeve Straight Multi-unit Screw Angled abutments 15° and 25° Angled abutments 15° Large Ball Attachments (1, 2 & 3 mm) Direct screw platform Straight abutments Screw retained abutments Straight Multi-unit abutments Healing caps Cover Screw The QUAD expansion is performed using a reusable Expansion Tool and Ratchet Torque.
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