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Accelx Implant System implants are indicated for use in partially or fully edentulous patients to support maxillary and mandibular single-unit, multiple-unit, and overdenture dental restorations. Accelx Implant System implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implant diameters larger than 6.0 mm are dedicated for the molar region and are indicated for delayed loading. Accelx Implant System implants are compatible with Accelx Implant System abutments. Accelx Implant System implants are compatible with MegaGen AnyRidge Internal Implant System titanium abutments as listed below. | Implant System Compatibility | Platform Diameter, mm | Maximum Angulation | |------------------------------------------|-----------------------|--------------------| | MegaGen AnyRidge Internal Implant System | 3.5, 4.0, 4.25, 5.0 | 25° | Accelx Implant System cover screws are compatible with MegaGen AnyRidge Internal Implant System components as listed below. | Implant System Compatibility | Implant Body Diameter, mm | Implant Platform, mm | |------------------------------------------|---------------------------|----------------------| | MegaGen AnyRidge Internal Implant System | 4.0 | 3.5 | | | 4.4 | 3.5 | | | 4.9 | 3.5, 4.0 | | | 5.4 | 3.5, 4.25 | | | 5.9 | 3.5, 4.25 | | | 6.4 | 5.0 | | | 6.9 | 5.0 | | | 7.4 | 5.0 | | | 7.9 | 5.0 | | | 8.4 | 5.0 |

The Accelx Implant System comprises Accelx dental implants, Accelx abutments previously cleared in K203240. The Accelx Implant System is compatible with the MegaGen AnyRidge Internal Implant System, regardless of the implant platform; this compatibility is due to the internal taper connection. Accelx dental implants have an internal taper abutment interface connection and an internal hexagonal feature for abutment anti-rotation and instrument. The internal threaded section is for mating to the corresponding Accelx cover screws, abutments and screws previously cleared in K203240, and MegaGen AnyRidge Internal Implant System restorative devices. Accelx dental implants are provided in ten body diameters ranging from 4.0 mm to 8.4 mm, and in total lengths ranging from 7.7 mm to 14.2 mm. Implants with a body diameter of 4.0 mm and 4.4 mm have a platform diameter of 3.5 mm. Implants with a body diameter of 4.9 mm have a platform diameter of 3.5 mm or 4.0 mm. Implants with a body diameter of 5.4 mm to 5.9 mm have a platform diameter of 3.5 mm. Implants with a body diameter of 6.4 mm to 8.4 mm have a platform diameter of 5.0 mm. The implants are manufactured from titanium alloy conforming to ASTM F136. The endosseous surface of the implant is aluminum oxide-blasted arom the implant collar to the apex. All Accelx dental implants are intended to be placed 0.5-1.0 mm sub crestal. Accelx cover screws are provided with a coronal diameter of 3.5 mm in overall lengths of 5.7 mm, 6.5 mm and gingival heights (cuff heights) of 0.8 mm, 1.6 mm, respectively. The cover screws are manufactured from titanium alloy confirming to ASTM F136 and anodized. The cover screws are single use only. The smallest cover screw is provided sterile within the Subject device implant packaging. They are also provided individually as replacement or alternative parts in the same non-sterile packaging configuration as cleared in K203240.