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510(k) Data Aggregation

    K Number
    K200078
    Device Name
    VARO Plan
    Manufacturer
    3D Industrial Imaging Co., Ltd.
    Date Cleared
    2020-04-10

    (87 days)

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

    3D Industrial Imaging Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VARO Plan Software is a stand-alone Windows-based software application to support the treatment planning for dental implantation. It is designed for qualified dental practitioners, including dentists and lab technicians. The software imports the medical image dataset of the patient in DICOM format from medical CT or dental CBCT scanners for pre-operative planning and simulation of dental placement. It is intended for use as pre-operative planning software for the placement of dental implant(s) based on imported CT image data, optionally aligned to an optical 3D surface scan. Virtual Crowns can be used for optimized implant positioning under the prosthetic aspect. The digital three dimensional model of a surgical guide for a guided surgery can be designed based on the approved implant position. This 3D data can be exported to manufacture a separate physical product. Indications of the dental implants do not change with guided surgery compared to conventional surgery. Use of the software requires that the user has the necessary medical training in implantology and surgical dentistry.
    Device Description
    VARO Plan is a pure software device. VARO Plan is a dental implant surgical guide design software that is used to design surgical procedure guidelines for implanting one or more dental implants based on CT and the Tray data. Implant library, which includes certified implants, and sleeve libraries are provided. The guide model designed in accordance with the established dental implant operation plan can be exported as STL files. The followings are the major functions of VARO Plan. - Patient Management and Surgical Plan Management - Data Management and Matching - Crown Model Management and Mesh Edit - Panoramic Screen Generation and Nerve Setting - Implant Simulation - Surgical Guide Design - Results output. - Report - Project Information Management
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    K Number
    K183676
    Device Name
    DentiqAir
    Manufacturer
    3D Industrial Imaging Co., Ltd.
    Date Cleared
    2019-12-19

    (356 days)

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

    3D Industrial Imaging Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DentiqAir is a software application for the visualization of imaging information of the oralmaxillofacial region. The imaging data originates from medical scanners such as CT or CBCT scanners. The dental professionals' planning data may be exported from DentiqAir and used as input data for CAD or Rapid Prototyping Systems.
    Device Description
    DentiqAir is a pure software device applied for the visualization of imaging information of the ear-nose-throat (ENT) region and oral-maxillofacial region. The imaging data originates from medical scanners such as CT or Cone Beam - CT (CBCT) scanners. This information can be complemented by the imaging information from optical impression systems. The medical professionals' input information and planning data may be exported from Dentiq Air to be used for CAD or Rapid Prototyping Systems.
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