| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 07332747149319 | 300516 | 300516 | Occlusion Guide Trefoil | NDP | Accessories, implant, dental, endosseous | 1 | Trefoil™ |
| 2 | 07332747113730 | 38738 | 38738 | On1 IOS Healing Cap 5 mm WP | NHA | ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | 2 | On1™ |
| 3 | 07332747034882 | 36720 | 36720 | Implant Driver CC RP 28mm | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 4 | 07332747096224 | 38177 | 38177 | Gold Cylinder 4mm | DZE | IMPLANT, ENDOSSEOUS, ROOT-FORM | 2 | NA |
| 5 | 07332747016529 | 6129 | 6129 | Implant Analog 6.0 HL/RPL | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 6 | 07332747014303 | 36117 | 36117 | Drill Tapered 2 mm | DZI | DRILL, BONE, POWERED | 2 | NobelReplace® |
| 7 | 07332747009040 | 29163 | 29163 | Screwdriver/Activator | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 8 | 07332747005820 | 33081 | 33081 | Drill Stop Ø4.2 | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 9 | 07332747000306 | 34554 | 34554 | Abutment screw PS WP-RP | NHA | ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | 2 | NA |
| 10 | 17332747008125 | 38857 | 38857 | Protection Analog / Drill Guide CC WP 5/pkg | NDP | ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS | NA | |
| 11 | 17332747008118 | 38856 | 38856 | Protection Analog / Drill Guide CC RP 5/pkg | NDP | ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS | NA | |
| 12 | 17332747008101 | 38855 | 38855 | Protection Analog / Drill Guide CC NP 5/pkg | NDP | ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS | NA | |
| 13 | 17332747007975 | 38919 | 38919 | Multi-unit Abutment Plus Replica (5pkg) | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 14 | 17332747000211 | 29499 | 29499 | Implant Replica NobRpl NP 20/pkg | NDP | Accessories, implant, dental, endosseous | NobelReplace® | |
| 15 | 17332747001805 | 36804 | 36804 | Protection Analog CC 3.0 5/pkg | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 16 | 17332747001027 | 2413 | 2413 | Retainer Ring 2/pkg | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 17 | 17332747000976 | 61760 | 61760 | O-Ring for Tools 2 sets of 5/pkg | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 18 | 17332747000969 | 2078 | 2078 | O-Ring Clinical White 12/pkg | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 19 | 17332747000952 | 2493 | 2493 | O-Ring Abutment Analog w Spacer 2/pkg | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 20 | 17332747000402 | 62200 | 62200 | Abutment Scr, Slotted, 3.25HL/3.5, 4-Pk | NHA | ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | NA | |
| 21 | 17332747000266 | 30043 | 30043 | Protection Analog NobRpl 6.0 5/pkg | NDP | Accessories, implant, dental, endosseous | 1 | NobelReplace® |
| 22 | 17332747000235 | 29503 | 29503 | Implant Replica NobRpl WP 20/pkg | NDP | Accessories, implant, dental, endosseous | NobelReplace® | |
| 23 | 17332747000228 | 29501 | 29501 | Implant Replica NobRpl RP 20/pkg | NDP | Accessories, implant, dental, endosseous | NobelReplace® | |
| 24 | 17332747000174 | 29293 | 29293 | Lab Screw Implant Level NobRpl RP/WP/6.0 5/pkg | NDP | Accessories, implant, dental, endosseous | NobelReplace® | |
| 25 | 17332747000167 | 29290 | 29290 | Lab Screw Implant Level Bmk Syst RP 5pkg | NDP | Accessories, implant, dental, endosseous | 1 | Brånemark System® |
| 26 | 17332747000150 | 29287 | 29287 | Lab Screw Multi-unit 5/pkg | NDP | Accessories, implant, dental, endosseous | NA | |
| 27 | 17332747000143 | 29124 | 29124 | Protection Analog M-u Bmk Syst WP 5/pkg | NDP | Accessories, implant, dental, endosseous | 1 | Brånemark System® |
| 28 | 17332747000136 | 29123 | 29123 | Protection Analog Multi-unit 5/pkg | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 29 | 17332747000129 | 29121 | 29121 | Protection Analog NobRpl WP 5/pkg | NDP | Accessories, implant, dental, endosseous | 1 | NobelReplace® |
| 30 | 17332747000112 | 29120 | 29120 | Protection Analog NobRpl RP 5/pkg | NDP | Accessories, implant, dental, endosseous | 1 | NobelReplace® |
| 31 | 17332747000105 | 29119 | 29119 | Protection Analog NobRpl NP 5/pkg | NDP | Accessories, implant, dental, endosseous | 1 | NobelReplace® |
| 32 | 17332747000099 | 29118 | 29118 | Protection Analog Bmk Syst WP 5/pkg | NDP | Accessories, implant, dental, endosseous | 1 | Brånemark System® |
| 33 | 17332747000082 | 29117 | 29117 | Protection Analog Bmk Syst RP 5/pkg | NDP | Accessories, implant, dental, endosseous | 1 | Brånemark System® |
| 34 | 17332747000075 | 29116 | 29116 | Protection Analog Bmk Syst NP 5/pkg | NDP | Accessories, implant, dental, endosseous | 1 | Brånemark System® |
| 35 | 07332747015195 | 35426 | 35426 | Guide Drill | DZI | DRILL, BONE, POWERED | 2 | NA |
| 36 | 07332747178920 | PUR0901 | PUR0901 | NobelSpeedy/Brånemark Syst/Replace Sel TC PureSet™ Plate | KCT | Sterilization wrap containers, trays, cassettes & other accessories | 2 | NA |
| 37 | 07332747178913 | PUR0900 | PUR0900 | NobelSpeedy/Brånemark Syst/Replace Sel TC PureSet™ Tray | KCT | Sterilization wrap containers, trays, cassettes & other accessories | 2 | NA |
| 38 | 07332747177831 | 301202 | 301202 | Lab Screw MUA Omnigrip Mini WP | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 39 | 07332747177824 | 301201 | 301201 | Lab Screw MUA Omnigrip Mini NP/RP | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 40 | 07332747177756 | 300496 | 300496 | Pos Loc Multiple Strmn Std/Plus 6.5 | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 41 | 07332747177749 | 300495 | 300495 | Pos Loc Multiple Strmn Std/Plus 4.8 | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 42 | 07332747177732 | 300494 | 300494 | Pos Loc Multiple Strmn BLvl RC4.1/4.8 | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 43 | 07332747177725 | 300493 | 300493 | Pos Loc Multiple Strmn BLvl NC3.3 | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 44 | 07332747177718 | 29121 | 29121 | Protection Analog NobRpl WP 5/pkg | NDP | Accessories, implant, dental, endosseous | 1 | NobelReplace® |
| 45 | 07332747177701 | 29120 | 29120 | Protection Analog NobRpl RP 5/pkg | NDP | Accessories, implant, dental, endosseous | 1 | NobelReplace® |
| 46 | 07332747177695 | 29119 | 29119 | Protection Analog NobRpl NP 5/pkg | NDP | Accessories, implant, dental, endosseous | 1 | NobelReplace® |
| 47 | 07332747177350 | 38857 | 38857 | Protection Analog/Drill Guide CC WP 5/pk | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 48 | 07332747177343 | 38856 | 38856 | Protection Analog/Drill Guide CC RP 5/pk | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 49 | 07332747177336 | 38855 | 38855 | Protection Analog/Drill Guide CC NP 5/pk | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 50 | 07332747177329 | DIB 097-0 | DIB 097-0 | Cover Screw Driver Bmk Syst Hexagon | NDP | Accessories, implant, dental, endosseous | Brånemark System® |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 08809278790307 | Xelis Dental 2.0 | Xelis Dental 2.0 | INFINITT HEALTHCARE CO.,LTD. | ||
| 2 | 08809278790192 | INFINITT RT PACS | INFINITT RT PACS | INFINITT HEALTHCARE CO.,LTD. | ||
| 3 | 08809278790130 | INFINITT PACS 7.0 | INFINITT PACS | INFINITT HEALTHCARE CO.,LTD. | ||
| 4 | 08809278790123 | INFINITT ULite | INFINITT ULite | INFINITT HEALTHCARE CO.,LTD. | ||
| 5 | 08809278790116 | Xelis Dental | Xelis Dental | INFINITT HEALTHCARE CO.,LTD. | ||
| 6 | 08809278790109 | Xelis Cardiac | Xelis Cardiac | INFINITT HEALTHCARE CO.,LTD. | ||
| 7 | 08809278790093 | Xelis Fusion | Xelis Fusion | INFINITT HEALTHCARE CO.,LTD. | ||
| 8 | 08809278790086 | Xelis 3D | Xelis 3D | INFINITT HEALTHCARE CO.,LTD. | ||
| 9 | 08809278790079 | Xelis | Xelis | INFINITT HEALTHCARE CO.,LTD. | ||
| 10 | 08809278790062 | INFINITT Cardiology PACS | INFINITT Cardiology PACS | INFINITT HEALTHCARE CO.,LTD. | ||
| 11 | 08809278790055 | INFINITT PACS | INFINITT PACS | INFINITT HEALTHCARE CO.,LTD. | ||
| 12 | 08809278790000 | STARPACS | STARPACS | INFINITT HEALTHCARE CO.,LTD. | ||
| 13 | 08806167789466 | USO-U0N5B0K/WR | 5D Viewer | SAMSUNG MEDISON CO., LTD. | ||
| 14 | 08806167761172 | USO-U0N5B0B/WR | 5D VIEWER | SAMSUNG MEDISON CO., LTD. | ||
| 15 | 08800086200064 | V-B-pAb-02 | Veuron-Brain-pAb2 | HEURON CO.,LTD. | ||
| 16 | 08800086200026 | V-B-pAb-01 | Veuron-Brain-pAb | HEURON CO.,LTD. | ||
| 17 | 08800086200019 | V-B-mN1-01 | Veuron-Brain-mN1 | HEURON CO.,LTD. | ||
| 18 | 08800046800006 | 1.1.0 | ClariCT.AI | CLARIPI INC. | ||
| 19 | 08800025300084 | 1.1 | AVIEW LCS | CORELINE SOFT CO.,LTD. | ||
| 20 | 08800025300077 | 1.1 | AVIEW | CORELINE SOFT CO.,LTD. | ||
| 21 | 08800025300039 | 1.0 | AVIEW LCS | CORELINE SOFT CO.,LTD. | ||
| 22 | 08800025300022 | 1.1 | AVIEW Modeler | CORELINE SOFT CO.,LTD. | ||
| 23 | 08800025300015 | 1.0 | AVIEW | CORELINE SOFT CO.,LTD. | ||
| 24 | 08800023100006 | 1.0 | OnDemand3DTM | CYBERMED INC. | ||
| 25 | 08800022900089 | 1.0 | 1.0 | VARO Plan Software is a stand-alone Windows-based software application to suppor 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. | VARO Plan | 3D INDUSTRIAL IMAGING CO.,LTD |
| 26 | 08800022900072 | 1.0 | DentiqAir is a software application for the visualization and segmentation of im DentiqAir is a software application for the visualization and segmentation of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or CBCT scanners. The software is intended to create design outputs to fabricate intraoral mandibular advancement devices used for the reduction of snoring. The dental professionals' planning data may be exported from DentiqAir and used as input data for CAD or Rapid Prototyping Systems. Output of DentiqAir has not been 510(k) cleared yet. The export of the device design file should only be sent to manufacturer who hold a 510(k) for intraoral mandibular advancement devices using DentiqAir software. The manufacture of the device should occur as per the design specifications provided within the 510(k) clearance. | DentiqAir | 3D INDUSTRIAL IMAGING CO.,LTD | |
| 27 | 08800022900041 | 1.0 | DentiqGuide is a software device used to pre-operatively plan the placement of a DentiqGuide is a software device used to pre-operatively plan the placement of a dental implant and to visualize a patient’s CT image optionally aligned to an optical 3D surface data. Virtual crowns can be used to guide the planning under the final prosthetic aspect. The surgical guide data can be designed then exported to an external system for manufacturing. Key Lock. | DentiqGuide | 3D INDUSTRIAL IMAGING CO.,LTD | |
| 28 | 08800022900003 | 1.0 | 1.0 | Dentiq3D is a 3D visualization software for the analysis of various dental CT da Dentiq3D is a 3D visualization software for the analysis of various dental CT data. Dentiq3D provides intuitive and real-time 3D volume processing functions. | Dentiq3D | 3D INDUSTRIAL IMAGING CO.,LTD |
| 29 | 08800019700357 | 3.3 | EzDent-i is dental imaging software that is intended to provide diagnostic tools EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. EzDent-i is intended for use as software to acquire, view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment. | EzDent-i | EWOO SOFT CO., LTD | |
| 30 | 08800019700340 | 5.4 | Ez3D-i is dental imaging software that is intended to provide diagnostic tools f Ez3D-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. Ez3D-i is intended for use as software to load, view and save DICOM images from CT, panorama, cephalometric and intraoral imaging equipment and to provide 3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions. | Ez3D-i | EWOO SOFT CO., LTD | |
| 31 | 08800019700319 | 1.3 | EzOrtho is a software indicated for use by dentists who provide orthodontic trea EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO/STO and patient consultation. Results produced by the software’s diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists. | EzOrtho | EWOO SOFT CO., LTD | |
| 32 | 08800019700258 | 1.2 | EzOrtho is a software indicated for use by dentists who provide orthodontic trea EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO/STO and patient consultation. Results produced by the software’s diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists. | EzOrtho | EWOO SOFT CO., LTD | |
| 33 | 08800019700241 | v1.0 | EzDent Web is a dental imaging software that enables you to save, manage, view a EzDent Web is a dental imaging software that enables you to save, manage, view and process patients’ images. EzDent Web is equipped with management and processing system for various 2D and 3D images. In addition, EzDent Web provides media contents for patient consultation and user friendly instruction to assist your use of the software.EzDent Web provides you with the following functions using patient images in 2D and 3D.- Manage patient information- View patient images in 2D/3D using tools for image processing and view function.- Use high resolution 3D VR to view 3D images in the optimized view for user intent.- Consult patients using media contents provided for patient consultation. | EzDent Web | EWOO SOFT CO., LTD | |
| 34 | 08800019700234 | v5.3 | Ez3D-i is dental imaging software that is intended to provide diagnostic tools f Ez3D-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. Ez3D-i is intended for use as software to load, view and save DICOM images from CT, panorama, cephalometric and intraoral imaging equipment and to provide 3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions. | Ez3D-i | EWOO SOFT CO., LTD | |
| 35 | 08800019700227 | v3.2 | EzDent-i is dental imaging software that is intended to provide diagnostic tools EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. EzDent-i is intended for use as software to acquire, view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment. | EzDent-i | EWOO SOFT CO., LTD | |
| 36 | 08800019700203 | 1.1 | EzOrtho is a software indicated for use by dentists who provide orthodontic trea EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO/STO and patient consultation. Results produced by the software’s diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists. | EzOrtho | EWOO SOFT CO., LTD | |
| 37 | 08800019700197 | v3.1 | EzDent-i is dental imaging software that is intended to provide diagnostic tools EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. EzDent-i is intended for use as software to acquire, view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment. | EzDent-i | EWOO SOFT CO., LTD | |
| 38 | 08800019700180 | v3.0 | Smart M Viewer(EzDent-i OEM) is medical imaging software that is intended to pro Smart M Viewer(EzDent-i OEM) is medical imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. Smart M Viewer (EzDent-i OEM) is intended for use as software to acquire, view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment. | Smart M Viewer | EWOO SOFT CO., LTD | |
| 39 | 08800019700173 | v5.2 | Ez3D-i is dental imaging software that is intended to provide diagnostic tools f Ez3D-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. Ez3D-i is intended for use as software to load, view and save DICOM images from CT, panorama, cephalometric and intraoral imaging equipment and to provide 3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions. | Ez3D-i | EWOO SOFT CO., LTD | |
| 40 | 08800019700159 | 1.0 | EzOrtho is a software indicated for use by dentists who provide orthodontic trea EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO/STO and patient consultation. Results produced by the software’s diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists. | EzOrtho | EWOO SOFT CO., LTD | |
| 41 | 08800019700142 | v1.1 | EzMobile is dental imaging software that is intended to provide diagnostic tools EzMobile is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist.EzMobile is intended for use as software to acquire, view and save 2D image files, load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment. | EzMobile | EWOO SOFT CO., LTD | |
| 42 | 08800019700128 | v5.1 | Ez3D-i is dental imaging software that is intended to provide diagnostic tools f Ez3D-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. Ez3D-i is intended for use as software to load, view and save DICOM images from CT, panorama, cephalometric and intraoral imaging equipment and to provide 3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions. | Ez3D-i | EWOO SOFT CO., LTD | |
| 43 | 08800019700111 | v3.0 | EzDent-i is dental imaging software that is intended to provide diagnostic tools EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. EzDent-i is intended for use as software to acquire, view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment. | EzDent-i | EWOO SOFT CO., LTD | |
| 44 | 08800019700098 | v5.0 | Ez3D-i is dental imaging software that is intended to provide diagnostic tools f Ez3D-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. Ez3D-i is intended for use as software to load, view and save DICOM images from CT, panorama, cephalometric and intraoral imaging equipment and to provide 3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions. | Ez3D-i | EWOO SOFT CO., LTD | |
| 45 | 08800019700081 | v2.1 | OtrhoVision software is indicated for use by orthodontists for image analysis, s OtrhoVision software is indicated for use by orthodontists for image analysis, simulation, profilogram, growth forecast, VTO/STO and patient consultation. Results produced by the software’s diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists. | OrthoVision | EWOO SOFT CO., LTD | |
| 46 | 08800019700074 | v2.3 | EzDent-i is dental imaging software that is intended to provide diagnostic tools EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. EzDent-i is intended for use as software to acquire, view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment. | EzDent-i | EWOO SOFT CO., LTD | |
| 47 | 08800019700067 | v4.3 | Ez3D-i is dental imaging software that is intended to provide diagnostic tools f Ez3D-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist.Ez3D-i is intended for use as software to load, view and save DICOM images from CT, panorama, cephalometric and intraoral imaging equipment and to provide 3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions. | Ez3D-i | EWOO SOFT CO., LTD | |
| 48 | 08800019700050 | v2.2 | EzDent-i is dental imaging software that is intended to provide diagnostic tools EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. EzDent-i is intended for use as software to acquire, view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment. | EzDent-i | EWOO SOFT CO., LTD | |
| 49 | 08800019700036 | v1.2 | Ez3D Plus is dental imaging software that is intended to provide diagnostic tool Ez3D Plus is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. Ez3D Plus is intended for use as software to load, view and save DICOM images from CT, panorama, cephalometric and intraoral imaging equipment and to provide 3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions. | Ez3D Plus | EWOO SOFT CO., LTD | |
| 50 | 08800019700029 | v2.0 | OtrhoVision software is indicated for use by orthodontists for image analysis, s OtrhoVision software is indicated for use by orthodontists for image analysis, simulation, profilogram, growth forecast, VTO/STO and patient consultation. Results produced by the software’s diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists. | OrthoVision | EWOO SOFT CO., LTD |