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coDiagnostiX is an implant planning and surgery planning software tool intended for use by dental professionals who have appropriate knowledge in the field of application. The software reads imaging information output from medical scanners such as CBCT or CT scanners. It is indicated for pre-operative simulation and evaluation of patient anatomy, dental implant placement, surgical instrument positioning, and surgical treatment options, in edentulous, partial edentulous or dentition situations, which may require a surgical guide. It is further indicated for the user to design such guides for, alone or in combination, the guiding of a surgical path along a trajectory or a profile, or to help evaluate a surgical preparation or step. coDiagnostiX software allows for surgical guide export to a validated manufacturing center or to the point of care. Manufacturing at the point of care requires a validated process using CAM equipment (additive manufacturing system, including software and associated tooling) and compatible material (biocompatible and sterilizable). A surgical guide may require to be used with accessories.

The main uses and capabilities of the coDiagnostiX software are unchanged from the primary predicate version. As in the primary predicate version, it is a software for dental surgical treatment planning. It is designed for the evaluation and analysis of 3-dimensional datasets and the precise image-guided and reproducible preoperative planning of dental surgeries. The first main steps in its workflow include the patient image data being received from CBCT (Cone Beam Computed Tomography) or CT. The data in DICOM format is then read with the coDiagnostiX DICOM transfer module according to the standard, converted into 3-dimensional datasets and stored in a database. The pre-operative planning is performed by the computation of several views (such as a virtual Orthopantomogram or a 3-dimensional reconstruction of the image dataset), by the analysis of the image data, and the placement of surgical items (i.e. sleeves, implants) upon the given views. The pre-operative planning is then followed as decided by the design of a corresponding surgical guide that reflects the assigned placement of the surgical items. Additional functions are available to the user for refinement of the preoperative planning, such as: - · Active measurement tools, length and angle, for the assessment of surgical treatment options: - · Nerve module to assist in distinguishing the nervus mandibularis canal; - 3D sectional views through the jaw for fine adjustment of surgical treatment options; . - Segmentation module for coloring several areas inside the slice dataset, e.g., jawbone, . native teeth, or types of tissue such as bone or skin, and creating a 3D reconstruction for the dataset; - Parallelizing function for the adjustment of adjacent images; and - · Bone densitometry assessment, with a density statistic in areas of interest. All working steps are automatically saved to the patient file may contain multiple surgical treatment plan proposals which allows the user to choose the ideal surgical treatment plan. The output file of the surgical guide and/or the guided surgical is then generated from the final surgical treatment plan. coDiagnostiX software allows for surgical guide export to a validated manufacturing center or to the point of care. Manufacturing at the point of care requires a validated process using CAM equipment (additive manufacturing system, including software and associated tooling) and compatible material (biocompatible and sterilizable). A surgical quide may require to be used with accessories.