EzDent Web

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration". Ewoosoft Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Karman Ave., STE 160 IRVINE CA 92612 September 28, 2021 Re: K211700 Trade/Device Name: EzDent Web Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: August 24, 2021 Received: August 30, 2021 Dear Priscilla Chung: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809; medical device reporting of medical device-related adverse events) (21 CFR {1}------------------------------------------------ 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K211700 Device Name EzDent Web #### Indications for Use (Describe) EzDent Web is a dental imaging software that is intended to provide viewer and image processing tools for maxillofacial radiographic images. 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 Web is intended for use as software to acquire, view, and save 2D image files, to load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment, and to provide 3D visualization and 2D analysis. EzDent Web is not for use for diagnostic purposes. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary (K211700) This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92. #### 1. Date: 8/24/2021 #### 2. Applicant / Submitter Ewoosoft Co., Ltd. 801-ho, Vatechnetworks Bldg., 13, Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggido , Republic of Korea Tel: +82 31 8015 6172 Fax: +82 31 8015 6196 Contact person: Young Seok Kim Email: eddie.kim@ewoosoft.com #### 3. U.S. Designated Agent Priscilla Chung LK Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160 Irvine, CA 92612 Fax: 714.409.3357 Tel: 714.202.5789 Email: juhee.c@LKconsultingGroup.com #### 4. Device Information: - Trade/Device Name: EzDent Web - Regulation Number: 21 CFR 892.2050 - Regulation Name: Medical Image Management and Processing System ● - Regulatory Class: Class II - o Product Code: LLZ #### 5. Predicate Device: - Manufacturer: Ewoosoft Co., Ltd. - Trade/Device name: EzDent-i(E2/ProraView/Smart M viewer) / Ez3D-i v5.2(E3) - 510(k) number: K202116 / K200178 - Regulation number 21 CFR 892.2050 ● - o Regulation name: Picture Archiving and Communications System - Regulatory Class: Class II ● - Classification Product Code: LLZ #### Page 1 of 5 {4}------------------------------------------------ #### 6. Device Description: 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 can be used in a networked environment. If EzDent Web is installed in several computers, the patient and image database can be shared among them and used on different workstations. #### 7. Indication for use: EzDent Web is a dental imaging software that is intended to provide viewer and image processing tools for maxillofacial radiographic images. 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 Web is intended for use as software to acquire, view, and save 2D and 3D image files, to load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment, and to provide 3D visualization and 2D analysis. EzDent Web is not for use for diagnostic purposes. {5}------------------------------------------------ # Substantial Equivalence ප්‍ | Device name | Subject Device | Predicate Device | | |-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510K number | EzDent Web | EzDent-i(E2/ProraView/Smart M viewer) | Ez3D-i v5.2(E3) | | Manufacturer | K211700<br>Ewoosoft Co., Ltd | K202116<br>Ewoosoft Co., Ltd. | K200178<br>Ewoosoft Co., Ltd. | | Indications for use | EzDent Web is a dental imaging software that is intended to provide viewer and image processing tools for maxillofacial radiographic images. 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 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 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 Web is intended for use as software to acquire, view, and save 2D and 3D image files, to load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment, and to provide 3D visualization and 2D analysis. | EzDent-i 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. | 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 | | Technology/Principle of Operation | EzDent Web is a device that provides various features to acquire, transfer, edit, display, store, and perform digital processing of medical images. EzDent Web is a patient & image management software specifically for digital dental radiography. It also provides server/client model so that the users upload and download clinical diagnostic images and patient information from any workstations in the network environment. | EzDent-i is a device that provides various features to acquire, transfer, edit, display, store, and perform digital processing of medical images. EzDent-i is a patient & image management software specifically for digital dental radiography. It also provides server/client model so that the users upload and download clinical diagnostic images and patient information from any workstations in the network environment. | Ez3D-i can view, transfer and process 3D radiographs. Furthermore, it supports Smart Click, Smart Clipping, Implant Simulation and Canal Draw. | | Platform | EzDent-i supports general image formats such as JPG and BMP for 2D,3D image viewing as well as DICOM format.<br>IBM-compatible PC or PC network | EzDent-i supports general image formats such as JPG and BMP for 2D image viewing as well as DICOM format.<br>IBM-compatible PC or PC network | IBM-compatible PC or PC network | {6}------------------------------------------------ | Operating System | User Interface | Image Input Sources | 32 bit / 64 bit | Image format | Patient Database | Compatibility | Includes Image | Measurement tools | Image viewing | Image manipulation | Implant module | Image annotation | |---------------------------|-----------------|--------------------------------------------------------------------------------------------------------------------|-----------------|-----------------|------------------|--------------------------------------------------------|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|------------------| | Microsoft Windows 10 | Mouse, Keyboard | Images can be scanned, loaded from digital cameras or card readers, or imported from a radiographic imaging device | 32 / 64 bit | DICOM, JPG, BMP | SQL | Linear distance, Angle, Profile | Full, side by side, gallery, thumbnail | Brightness, contrast, sharpness, inverse, film view, rotate, zooming, draw canal, memo, implant simulations | Generic implant libraries | Text, paint, ellipse, pointer, select, draw, magnify, line, rectangle, polygon, ruler, protractor, reduction, select region, copy / paste | | | | Microsoft Windows 7, 8,10 | Mouse, Keyboard | Images can be scanned, loaded from digital cameras or card readers, or imported from a radiographic imaging device | 32/64 bit | DICOM, JPG, BMP | SQL | Linear distance, Angle, Profile | Full, side by side, gallery, thumbnail | Brightness, contrast, sharpness, inverse, film view, rotate, zooming, whitening, nerve canal tracing, memo | Generic implant libraries | Text, paint, ellipse, pointer, select, draw, magnify, line, rectangle, polygon, ruler, protractor, smile library, smudge, brush, redeye reduction, select region.copy/paste | | | | Microsoft Window 7, 8, 10 | Mouse, Keyboard | Images can be scanned, loaded from digital cameras or card readers, or imported from a radiographic imaging device | 32/64 bit | DICOM | SQL | Length, Multi Length, Angle, ROI/Area, Volume, Profile | Full, side by side, gallery, thumbnail | Grayscale, invert, emboss, brightness, contrast, gamma, sharpen, median, despeckle, hue, saturation, equalize, flip, mirror, masking, rotate, magnify, annotation, cephalometric tracing, ceph growth projections, implant simulations | Generic implant libraries | Text, paint, ellipse, pointer, select, draw, magnify, line, rectangle, polygon, ruler, protractor, smile library, smudge, brush, redeye reduction, select region, copy / paste | | | EzDan We das this Slottains in tack archives ar the as and technical characterisis a ta EDDal Mob Mot Mot Mot Mot Mot Mot Mot Mot Mot Mot Mor Mor Mercion and Eraber aner ante The difference is that the EzDent Web uses is a web base so that the users can easily access the program and view 2D and 3D images at the same time. The difference is the EZDen Wob use is a wob base so that the users the program and view 2D and 3D mages at the same time. We performed SW validate that the subject devices f {7}------------------------------------------------ #### 9. Technological Characteristics: EzDent Web is a software device that does not contact the patient, nor does it control any life sustaining devices. Results produced by the software's diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed radiologists, clinicians and referring physicians as an adjunctive to standard radiology practices for diagnosis. #### 10. Performance Data: SW verification/validation and the measurement accuracy test were conducted to establish the performance, functionality and reliability characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria. #### 11. Conclusion: The subject device is substantially equivalent in the areas of technical characteristics, general function, application, and indications for use. The new device does not introduce a fundamentally new scientific technology, and the device has been validated through system level test. Therefore, we conclude that the subject device described in this submission is substantially equivalent to the predicate device.