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510(k) Data Aggregation

    K Number
    K151757
    Device Name
    IMMEDIATELOAD Dental Implant System
    Manufacturer
    Date Cleared
    2016-08-03

    (401 days)

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

    IMMEDIATELOAD S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IMMEDIATELOAD Dental Implant System is intended to be surgically inserted into the jawbone for support and retention of dental prosthesis such as artificial teeth, crowns, bridges and overdenture to restore the aesthetics of the patient and the mastication function. The IMMEDIATELOAD dental implant system is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. The UNIVERSE implants can be used for surgery in two stages or in single stage. The POWER and SOLUTION implants can be used for surgery in single stage.
    Device Description
    All IMMEDIATELOAD dental implants have a double external thread that looks flattened from the proximal area to the distal area. There are three types of implants: UNIVERSE (conical biphasic), POWER (conical monophasic), and SOLUTION (cylindrical monophasic), available in different diameters and length combinations. All the implants are made of Titanium Grade 4. They are provided sterile and are ready to be implanted. For each measure, the connection between the biphasic implant and the relative prosthetic component is secured by a locking taper connection and a preformed hexagon and by a retained screw. The abutments are prosthetic accessories made of Titanium Grade 5; they are used to engage, form and create dentures. In particular, the abutment is designed to be applied on the biphasic implant during the surgical reopening, after osseointegration. The straight abutment IMMEDIATE has a straight axis compared to implant's axis. It has a transmucosal collar height ranging from 1 mm to 4 mm. The inclined abutment IMMEDIATE has axis inclined of 15° compared to the implant's axis. It has a transmucosal collar height ranging from 1 mm to 3 mm. These abutments are fixed to the UNIVERSE implant via a connection screw. The OTK abutment is straight and contains an internal connection screw. It has a transmucosal collar height from 1 mm to 3 mm. The abutments are provided non-sterile and the connection screw for abutments are all provided non-sterile and are intended to be sterilized before use.
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