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510(k) Data Aggregation

    K Number
    K071803
    Device Name
    ARDS DENTAL IMPLANTS
    Manufacturer
    ARDS, LTD
    Date Cleared
    2008-09-05

    (431 days)

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

    ARDS, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ARDS dental implants are indicated for use in surgical and restorative applications for placement in the bone of the upper and lower jaw to provide support for prosthetic devices in order to restore the patient's chewing function. ARDS dental implants are indicated for two-stage surgery.
    Device Description
    ARDS implants are made from Titanium alloy. The ARDS implants geometrical shape is characterized by altering drilling profile, with double thread at the upper part that change to one thread at the lower part, which increases its surface, and as a result, increases in the preliminary contact surface with the bone. The ARDS dental implants are : S type: Internal hex implants, length 10/13 mm, diameter 3.75/4.5 mm, with double thread at the upper part that goes over in a single thread at the lower part. S implant types are supplied sterile in a double vial system, inside a plastic box which includes the covering screw and the Instructions For Use. The abutments are for single use only and supplied non-sterile. The tools are reusable and supplied non-sterile, they must be sterilized by autoclave before use.
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