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510(k) Data Aggregation

    K Number
    K232698
    Device Name
    NemoScan
    Manufacturer
    Software Nemotec S.L.
    Date Cleared
    2024-01-18

    (135 days)

    Product Code
    QIH, LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Software Nemotec S.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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. The software reads imaging information output from medical scamers such as CBCT or CT scanners. It is indicated for pre-operative simulation of patient anatomy, dental implant placement, surgical instrument positioning, and surgical treatment options, in 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. NemoScan 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. NemoScan is intended to be used only for Adolescents (12-21 years of age) to adults (>21 years of age) patients.
    Device Description
    NemoScan is a comprehensive diagnosis and treatment planning software for dental implantology intended to be used by dental professionals who have appropriate knowledge in surgical implantology and dental implants prosthesis. The software works with volume data sets imported from DICOM format produced by third-party CT/CBCT scanners and stored in a filedata repository. Additionally, optical scans of dental impressions can be imported from standard file formats like STL or PLY and registered over the volume to get reliable high definition of the anatomy of teeth and gums of the patients. The software is provided in three configurations: desktop, cloud and web. Surgical planning is performed through convenient layouts of views, analysis of image data and the placement of virtual dental implants and optionally virtual prosthetic teeth. One patient file may contain multiple surgical plan proposals which allow the user to choose the ideal surgical plan. Additional functions are available to the user for refinement of the surgical planning, such as: - Import, organize, store images from CT or CBCT in DICOM format (optionally if the case has these images, called Volume Images). - Import digital impressions of the teeth (scanned stone models and intraoral scanner) and/or implant files in STL or PLY format, and align them over the volume image (if exists). - Import facial scanner or 3D photos in OBJ or PLY format. - Measurements of distances and angles in 2D, for slices, and 3D, for 3D views. - Merge the dental digital impressions into the CT/CBCT patient volume. - Do Orientation of the Volume according to the Natural Head Position of the patient (Reorient the 3D volume). - Patient gums, teeth, bones, mandibular nerves and sinus segmentation to help the planner in viewing those anatomical conditions in 3D and their corresponding cross sections in the 2D slices. - Possibility of simulation of teeth extractions for immediate implants placement. - Specific layouts of views with the selected implant centered to accurately positioning the virtual implant according to the anatomical volume conditions. - Bone densitometry with a density statistic for density measuring in the area around a distance outside and inside the limits of the positioned implant. - Real time distances and angles to sensible areas like other implants, nerves, patient teeth, sinus, etc. - Possibility of adding prosthetic teeth for designing the immediate loading prosthesis or just for helping in orienting the implants according to the prosthetic conditions. NemoScan works with many manufacturers of implants, abutments, drills, analog, sleeves, hand pieces, etc., libraries to be used for simulation and treatment planning. The software allows importing these libraries and designing different kinds of surgical guides and immediate loading prosthesis to export the designed file in STL format. Finally, these designed files will be used to a validated manufacturing center or to the point of care. The device has no patient contact nor does it control any life-sustaining devices.
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    K Number
    K232549
    Device Name
    NemoCast
    Manufacturer
    Software Nemotec S.L.
    Date Cleared
    2023-11-21

    (90 days)

    Product Code
    PNN, LLZ
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    Software Nemotec S.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NemoCast is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options (Export of Models, Indirect Bonding Transfer Media) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned dectives. It can also be applied during the treatment to inspect and analyze the progress of the treatment. The use of the NemoCast requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.
    Device Description
    NemoCast is a software system used for the management of 3D scanned orthodontic models of the patients, orthodontic diagnosis by measuring, analyzing, inspecting and visualize 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, virtual placement of orthodontic brackets on the 3D models and design of orthodontic appliances based on 3D scanned orthodontic models, including transfer methods for indirect bonding of brackets. Output includes STL Models (also called dental casts) for thermoforming aligners, STL files for direct printing aligners and Indirect Bonding Transfer Trays (also called orthodontic bracket placement trays). The device has no patient contact.
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    K Number
    K193003
    Device Name
    NemoCast
    Manufacturer
    Software Nemotec S.L.
    Date Cleared
    2020-06-05

    (221 days)

    Product Code
    PNN, LZZ
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    Software Nemotec S.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NemoCast is intended for supporting the diagnostic and treatment plan processes for orthodontic procedures related to minor anterior tooth movements; it provides tools for management of orthodontic models, systemic inspection, detailed analysis, treatment simulation and virtual appliance design options (export of models) based on 3D models of the patient's dentition before the start of an orthodonic treatment. It can also be applied to evaluate if the outcome is consistent with the planned/desired treatment objectives. NemoCast requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.
    Device Description
    Not Found
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    K Number
    K192475
    Device Name
    NemoFAB
    Manufacturer
    Software Nemotec S.L.
    Date Cleared
    2020-04-23

    (226 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Software Nemotec S.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NemoFAB is a software indicated for supporting the diagnostic and treatment planning process of orthognathic procedures. NemoFAB is software that is also used as an image segmentation system and for the transfer of imaging information from a scanner such as a CT scanner. NemoFAB allows for the that can be transferred to a 3D printer for the creation of a splint, this splint will be used for aiding the surgeon in the placement of the bones in the orthognathic surgery according to the treatment plan.
    Device Description
    Not Found
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    K Number
    K192571
    Device Name
    NemoScan
    Manufacturer
    Software Nemotec S.L.
    Date Cleared
    2019-12-11

    (84 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Software Nemotec S.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NemoScan is software indicated for supporting the diagnostic and treatment planning process for Dental Implantology. NemoScan is software that is also used as an image segmentation system and for the transfer of imaging information from a scanner such as a CT scanner.
    Device Description
    Not Found
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