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Intended Use

NemoScan is an implant planning and surgery planning software tool intended for use by dental professionals who have appropriate knowledge in the field of application. It reads imaging information from CBCT or CT scanners, and is indicated for pre-operative simulation and evaluation of patient anatomy, dental implant placement, surgical instrument positioning, and surgical treatment options. It supports design and export of surgical guides.

Technology

NemoScan works with DICOM data sets obtained from CT or CBCT scanners and can import optical scans (STL, PLY) and 3D photos (OBJ). The software provides tools for image alignment, segmentation (teeth, gums, bones, nerves, sinus), implant placement, prosthetic simulation, bone density analysis, and surgical guide design. It exports guide designs in STL format for manufacturing. It operates as stand-alone software available as desktop, cloud, and web versions.

Performance

Performance testing includes verification and validation of software functionalities, risk assessment supported by clinical literature, and process performance qualifications for manufacturing surgical guides both at centralized centers and points of care. Testing confirms the device is safe and effective for intended use; sterilization and biocompatibility are out of scope for the software itself.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    9/5/2023

    4 months
  • 2

    FDA Approval

    1/18/2024

Other devices from Software Nemotec S.L.

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