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The Insight Dental Implant System is intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or fixed bridgework and dental retention. The Insight Dental Implant System is intended for delayed loading.

The Insight Dental Implant System is an integrated system of endosseous dental implants which are designed to support prosthetic devices for partially or fully endetulous patients. The Insight Dental Implant System consists of one-stage and two-stage root form dental implants and abutments, which provide the dentist with screw retained restoration options. The devices covered by this submission are implants, abutments, and healing caps. Implants are manufactured from titanium and feature a blasted finish on the threaded screw surface. The implants are provided in bone level and tissue level. The diameters of the implant fixtures are 3.5mm, 3.8mm, 4.6mm and 5.4mm; the lengths are 8.0mm, 10.0mm, and 12.0mm and is defined as the threaded implanted portion of the implant. Abutments are available in both standard and angled configurations. Abutments are manufactured from titanium. Standard abutments are straight, 4.6mm in diameter and sized for every implant diameter including 3.5mm, 4.6mm and 5.4mm. Angled abutments are 17°, 4.9mm in diameter and sized for every implant diameter including 3.5mm, 3.8mm, 4.6mm and 5.4mm. Healing caps are manufactured from titanium. The diameter of each healing cap matches an implant at 3.5mm, 3.8mm, 4.6mm and 5.4mm. Healing caps are straight. The dental implants provided consist of a straight wall or tapered body type with a basic screw-type design in various platform options and feature an internal connection and antirotation feature. Insight Dental Implant System is available with either prevail platform switching feature or standard collar. The Insight Dental System is packaged in a two section sterile tray with all of the implants and instruments needed for a single procedure included. All components of the system are intended for single use only.