| Primary Device ID | 08800022900089 |
| NIH Device Record Key | 664cf612-2619-4889-a9c3-76c25618457b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VARO Plan |
| Version Model Number | 1.0 |
| Catalog Number | 1.0 |
| Company DUNS | 688269503 |
| Company Name | 3D Industrial Imaging Co.,Ltd |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| 08800022900072 - DentiqAir | 2021-01-06 DentiqAir is a software application for the visualization and segmentation of imaging information of the oral-maxillofacial regi |
| 08800022900089 - VARO Plan | 2021-01-06VARO 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. |
| 08800022900089 - VARO Plan | 2021-01-06 VARO Plan Software is a stand-alone Windows-based software application to support the treatment planning for dental implantation |
| 08800022900041 - DentiqGuide | 2019-10-07 DentiqGuide is a software device used to pre-operatively plan the placement of a dental implant and to visualize a patient’s C |