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Custom Titanium Abutments are customizable devices intended for use with dental implants in the maxillary and/or mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients. - Custom Titanium Abutment for narrow (3.2mmD) implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements. - Custom Titanium Abutment for short (8mm) 3.7mmD implants: Indicated for tooth replacement of mandibular and maxillary central and lateral incisors. Custom Legacy Titanium Abutments are compatible at the implant-level with Legacy2, Legacy3, Legacy4, simplyLegacy2 and simplyLegacy3 implants, excluding 6mm length implants. Custom InterActive Titanium Abutments are compatible at the implant-level with InterActive, SimplyInterActive and SwishActive implants, excluding 6mm length implants.

The Custom Legacy Titanium Abutments and Custom InterActive Titanium Abutments (collectively the "Custom Titanium Abutments") are one-piece hex type engaging abutments comprised of Titanium 6AL-4V ELI, which serve as a final abutment upon which a prosthetic dental restoration will be fitted. The Custom Legacy Abutments are offered in 3.0mm, 3.5mm, and 5.7mm diameters that correspond to the platform diameters of the Legacy Implant System; the Custom InterActive Abutments are offered in 3.0mm and 3.4mm diameters that correspond to the InterActive Implant System. The devices are supplied with fixation screws that are placed through the abutment to secure it to the implant's reciprocal hex platform. The Custom Abutments are provided with a large amount of modifiable material to accommodate the digital workflow used for device customization. Customization of the final abutment is performed in Implant Direct's Custom Direct laboratory under Implant Direct's manufacturing control, where the devices are milled to meet individual patient specifications. The digital workflow uses the following additional devices: - 3Shape Abutment Design Software (K151455) - Dental System Control Panel - Dental Designer - Lab Scanner (3Shape D700 and 3Shape Scan-it Restoration Dental System (510(k)-exempt, Product Code NOF) - Intra-oral scanners - 3M True Definition Scanner (K122467) - Itero Scanner Software (K131101) The Custom Abutments are patient-specific and may be modified within the following parameters: - Maximum angle of 30° from the axis of the implant - Minimum wall thickness of 0.4mm - Minimum post height of 4mm The Custom Abutments are available using either a Design-and-Mill or Mill-only digital workflow. With the Design-and-Mill process flow, the patient's dentition information (impression or intraoral scan) is sent to Implant Direct. Implant Direct will design an abutment and forward the design to the end user for approval prior to manufacturing. With the Mill-only process flow, the end user uses intra-oral scanners and lab scanners to design the abutment using the 3Shape software. The abutment design file (.stl) is sent to Implant Direct for manufacturing. The Custom Abutments are single-use and supplied non-sterilization by the end user. They are externally-communicating devices which come in permanent contact (>30 days) with a patient's tissue/bone.

The InterActive Complete 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 sterilizable wrap and sterilized in an FDA cleared sterilizer for one of the following cycles: - (1) Prevaccum Steam At 132℃ for 4 minutes with a 20 minutes dry time. - (2) Gravity Steam At 132% for 15 minutes with a 30 minutes dry time. - The trays are intended for sterilization of non-porous loads. - The trays are recommended not to be stacked during sterilization. - The Complete Surgical Tray represents the worst case validated load due to the number of components) and the weight of 608.05 grams. - Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Interactive Complete Surgical Tray. - The tray will be marketed in following variations. | Device Model Name | Max no. of Instruments | Weight of each tray<br>with instruments (gms.) | |-------------------|------------------------|------------------------------------------------| | CST | 45 | 608.05 | | ICST | 34 | 467.26 | | IBST | 18 | 453.59 | | IST | 0 | 404.37 |

The InterActive Complete 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 insert tray has the ability to hold individualized pieces and accessories which include dental tools, drills, and ratchet. The tray is available in only one size of approximately 7.2 inches X 5.6 inches X 2.4 inches and will be marketed in four different variations – (1) InterActive Complete Surgical Tray (ICST) containing 34 instruments, (2) InterActive Basic Surgical Tray (IBST) containing almost half the number of instruments as ICST, (3) InterActive Surgical Tray (IST), empty tray containing no instruments, and (4) Complete Surgical Tray (CST), containing 45 instruments. 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 it 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 sterilization wrap must be used for sterilization purposes to maintain the sterility of the 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 K052992 and K012105. Radel R 5000 CL 301 is used for the lid, and Radel R 5100 NT15 is used for base and insert tray where all the drills and tools are mounted. The small circular brackets (grommets) throughout the insert tray which are used to contain the 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 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 tray are all non-porous devices and include dental surgical drills and tools. The tools are class I exempt and the drills have Class II pre-market notification clearance.