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510(k) Data Aggregation

    K Number
    K100902
    Device Name
    AEDIS(TM)
    Date Cleared
    2010-06-24

    (84 days)

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

    EMBED TECHNOLOGY LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AEDIS ™ provides a self tapping titanium screw indicated for immediate transitional splinting stability, or long term intra-bony applications such as fixation of new or existing crown, bridge or denture installations in partially or fully edentulous mandibles and maxillae. Immediate loading is not recommended where there is inadequate stability. Immediate loading should occur when the position of the implant provides adequate bone quality and quantity to allow proper immediate mechanical stabilization of the self tapping screw into the bone, and where occlusal and lateral forces can be limited with appropriate occlusal design when splinted. Dietary restrictions may also be required by the surgeon performing the implant procedure.
    Device Description
    The device is a Titanium alloy, root form implant system consisting of: a self-tapping 1.8 mm diameter implant screw with an integrated hexagonal fitment for attachment of an abutment, and a cap screw designed to lock the abutment to the implant screw. AEDIS™ abutments are not angled. AEDIS ™ follows natural tooth morphology and is recommended for use in mandibular and maxillary anterior locations for restoration applications. The screw diameter is 1.8mm and is offered in lengths of 13.5 and 15mm. A minimally invasive procedure allows for immediate placement, and temporization in single and multiple tooth restorations. The implant screws are self tapping. A titanium abutment is provided and is intended to be mechanically affixed to the screw to hold a crown, bridge, or other prosthetic appliance. The prosthesis may be secured to the abutment by the use of adhesives or mechanically by the use of a screw. The abutment is cone shaped; 8 mm in height; has a hexagonal fitment to provide for the cap screw) to lock the abutment the implant screw. The 5 mm diameter of the base of the abutment is identical to the diameter of the top of the implant screw. When all elements of the system are attached to each other the tolerances between the parts are 3 microns or less. Immediate loading is not recommended where there is inadequate stability. Immediate loading should occur when the position of the implant provides adequate bone quality and quantity to allow proper immediate mechanical stabilization of the self tapping screw into the bone, and where occlusal and lateral forces can be limited with appropriate occlusal design when splinted. Dietary restrictions may also be required by the surgeon performing the implant procedure. AEDIS™ is offered in a kit including: implant components; surgical instruments; a tissue punch, leveling bit, and implant insertion instruments. The package also includes recommended surgical protocols, and illustration of recommended insertion techniques. The kit is packaged in a plastic container with appropriate labeling. The AEDIS ™ is delivered in sterile condition, however many practitioners also autoclave the device in their own Operatories.
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