Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K011574
    Device Name
    UNIPLANT DENTAL IMPLANT SYSTEM
    Date Cleared
    2001-09-28

    (129 days)

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

    UNIVERSAL IMPLANT SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
    Device Description
    The Uniplant Dental Implant System is composed of a solid titanium alloy root-form implant and a solid conical abutment, with associated instruments. The implant is a screw-type, two-stage design, incorporating a titanium cover screw that seals the internal bore of the implant from the physiologic environment during healing. The implant is available in three diameters (3.4, 4.1 and 5.1 mm) and three implanted lengths (10 mm, 12 mm and 14 mm). The system includes surgical instruments such as drills, insertion modules and try-ins. The system includes a solid conical abutment that is intended to the implant by engaging the threaded shaft of the abutment in the internal threaded bore of the implant. The abutment includes a cylindrical transmucosal portion and a tapered, grooved coronal portion, with an internal hex socket at the coronal end to facilitate attachment to the implant. A prosthesis may be fabricated by means of standard crown and bridge techniques for attachment to the abutment.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1