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The Park Dental Research Corporation's LEW O-ball implant system is a self-tapping titanium threaded screw indicated for long-term intra-bony applications. Additionally, the LEW Mini O-ball Implant may be used for inter-radicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial edentulism, and employing minimally invasive surgical intervention. The 2.0mm , 2.5 mm, and 3.0 mm diameter are intended to support single or multi-unit restorations in both long-term and temporary applications throughout the maxillary and mandibular arches.

The LEW Mini O-ball implant (MD)) is available with a 1.5 mm gingival collar in three diameters: 2.0mm, and 3.0mm. The LEW Mini O-ball implant (MDI) is also available without a gingival collar in two diameters; 2.0mm and 2.5mm. The implant is made of Titanium alloy (Ti6A4V ELI per ASTM F 136-02), The thread surface is ablated with 50 micron aluminum oxide to remove shiny machined surface. The LEW Mini O-ball implant (MDI) is available in thread lengths ranging from 10mm to 18mm allowing for maximum bone engagement. The system consists of the major component, a root-form, screw type, self-tapping implant, and accessories designed to facilitate placing and using the implant. The accessories contact tissues for less than 1 hour and therefore are exempt from 510(k) requirements are described generally but are of course subject to general controls and are covered by the Quality System documents.

The Star/Vent Internal Hex Screw Implant is intended for placement in the bone of the upper or lower jaw to support prosthetic devices such as artificial teeth, crowns, bridges or overdentures in edentulous or partially edentulous patients and to restore the patient's chewing function. It is intended for immediate loading when good primary stability has been achieved and with appropriate occlusal loading,

The Park Star/Vent Internal Hex Screw Implant is a root form endosseous dental implant (FDA classification code DZE). It has been placed in class 2 per 21 CFR 872.3640. The device is fabricated from titanium alloy meeting the specifications of ASTM F136. It is available in lengths of 8, 10, 11.5, 13, and 16mm and diameters of 3.3, 3.75, 4.2, 5.0 and 6.0mm. The surface is treated with resorbable blast media. The device is provided sterile. Sterility is achieved by gamma radiation pursuant to ISO 11137 to provide a sterility assurance level (SAL) of 10-. This device includes straight abutments with a 1, 2, 3, or 4mm collar and a straight UCLA cast abutment with a titanium base. These abutments are composed of titanium alloy meeting the specifications of ASTM F-136.