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The Avinent Surgical Tray is designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared steam sterilizable wrap and sterilized in an FDA cleared sterilizer for the following cycle: Prevaccum Steam - At 132° for 4 minutes with a 30 minute dry time. -The trays are intended for sterilization of non-porous loads. -The trays are recommended not to be stacked during sterilization. -The Biomimetic Coral Sterilization Cassette Guided Surgery represents the worst case validated load due to the number of components (32 instruments) and the weight of 599.6 grams. -Avinent Implant System SLU does not make any lumen claims for the Avinent Surgical Tray. -The tray will be marketed in the variations found in the following table.

The Avinent Surgical Tray is a reusable rigid sterilization container or organizing tray intended for use in health care facilities for the purpose of containing reusable medical devices for sterilization. It is composed of multiple pieces, designed to be integrated into a single unit which contains and protects the interior components during sterilization. Each tray consists of three components – a base tray, a lid, and an internal individualized insert tray. All of the three components are perforated for steam penetration. The internal tray has the ability to hold individualized pieces and accessories which include dental tools, drills, and torque wrench. The tray is available in one size, 207.5 x 157.5 x 71.7mm. The tray comes in two variations, Coral and Ocean. The rigid multi-piece tray holds dental device apparatus and accessories before, during and after the sterilization process. The tray set has a locking lid to contain the products. The trays are designed to fit any standard autoclave, which allows them to be effective for sterilization and be able to withstand the environment of repeated steam sterilization cycles in normal operating room. Since the trays are perforated, an FDA cleared wrap must be used for sterilization purposes to maintain the sterility of contents. The trays are reusable and the tray material allows repeated sterilization cycles. The lid, base, and insert are made of Radel R-5000. This material is a polymer resin produced by Solvay Advanced Polymers, LLC and is identical to the Radel used in predicate device cleared under K142519. Radel R 5000 CL 301 is used for the lid, Radel R-5100 BK # 937 is used for the base and Radel R-5100 GY #1037 is used for the insert tray where all the drills and tools are mounted. The small circular brackets (grommets) throughout the insert tray which are used to contain drills and the tool holder with cradle on the base tray are made of medical grade silicone material which has been manufactured to meet FDA 21 CFR 177.2600. These brackets and holders are used to secure the instruments during transport, sterilization, and storage. Although these trays are reusable they will not be serviced or repaired. The instruments to be sterilized in the proposed trays are all non-porous devices and included dental surgical drills and tools. The tools and drills are all class I exempt.

The AVINENT dental implant system is for oral endosseous implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. AVINENT implants are for single-stage or two-stage surgical procedures and cement or screw retained restorations. Implants are intended for immediate loading on single-tooth and/or multiple tooth applicationswhen good primary stability is achieved and with appropriate occlusal loading, to restore chewing function if the requirements detailed in the surgical manual are satisfied. Specific indications for small diameter (03.3 mm implants): Because of their reduced mechanical stability, small diameter implants are only used in cases with a low mechanical load. Placement in maxillary lateral incisors or mandibular central and lateral incisors. The implant system serves as anchorage for dental prosthetic restorations. Implants are placed in the bone of the upper or lower jaw. Abutments are placed into the dental implant to provide support for the prosthetic reconstruction including abutments for cemented restorations to achieve better esthetics, Abutments can be used to restore crowns for single tooth replacements and bridges for multiple tooth restorations.

The proposed devices are threaded, root-form endosseous implants of various diameters and lengths and corresponding abutments. Implants are titanium alloy 6Al 4V, feature internal and external hex implant to abutment connection options and are available with modified surfaces (TO2 layer) to promote improved osseointegration. Implant abutments are also titanium alloy 6A1 4V. Instruments and accessories necessary to place implants and abutments also form part of the system.