K Number

Device Name

EzDent-i/ E2/ Prora View/ Smart M Viewer

Manufacturer

Ewoosoft Co., Ltd.

Date Cleared

2021-10-04

(116 days)

Product Code

LLZ

Regulation Number

892.2050

Intended Use

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.

Device Description

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. EzDent-i supports general image formats such as JPG and BMP for 2D image viewing as well as DICOM format. For 3D image management, it provides uploading and downloading support for dental CT Images in DICOM format. It interfaces with a 3D imaging software made by our company, the Ez3D-i (K131616, K150761, K161246, K163539, K173863, K190791, K200178) but the EzDent-i itself does not view, transfer or process 3D radiographs. EzDent-i supports the acquisition of dental images by interfacing with OpenCV library to import the intra-oral camera images. It also supports the acquisition of CT/Panoramic/Cephalo/Intra-Oral Sensor /Intra-Oral Scanner images by interfacing with Xray capture software.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K202116

Reference Devices

K131616,K150761,K161246,K163539,K173863,K190791,K200178

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard image processing and management features without mentioning AI or ML.

Therapeutic

No
EzDent-i is described as dental imaging software intended for diagnostic tools for maxillofacial radiographic imaging, and it processes medical images. It does not mention any therapeutic functions.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section states that EzDent-i is "dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging."

SaMD (Software as a Medical Device)

Yes

The device description explicitly states that EzDent-i is "patient & image management software" and describes its functions as acquiring, transferring, editing, displaying, storing, and performing digital processing of medical images. While it interfaces with hardware for image acquisition, the device itself is presented as a software solution for managing and processing these images.

IVD (In Vitro Diagnostic)

Based on the provided text, EzDent-i is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD devices are used to examine specimens derived from the human body. The text clearly states that EzDent-i is used for processing and viewing radiographic images of the maxillofacial region. These images are generated by imaging equipment, not by analyzing biological samples.
The intended use and device description focus on image acquisition, processing, display, and management. There is no mention of analyzing blood, tissue, or other bodily fluids or substances.
The input modalities are imaging devices. The text lists various types of dental imaging equipment as the source of the data.

Therefore, EzDent-i falls under the category of medical imaging software, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

LLZ

Device Description

EzDent-i supports general image formats such as JPG and BMP for 2D image viewing as well as DICOM format. For 3D image management, it provides uploading and downloading support for dental CT Images in DICOM format. It interfaces with a 3D imaging software made by our company, the Ez3D-i (K131616, K150761, K161246, K163539, K173863, K190791, K200178) but the EzDent-i itself does not view, transfer or process 3D radiographs.

EzDent-i supports the acquisition of dental images by interfacing with OpenCV library to import the intra-oral camera images. It also supports the acquisition of CT/Panoramic/Cephalo/Intra-Oral Sensor /Intra-Oral Scanner images by interfacing with Xray capture software.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

panorama, cephalometric, and intra-oral imaging equipment.
CT/Panoramic/Cephalo/Intra-Oral Sensor /Intra-Oral Scanner images

Anatomical Site

maxillofacial

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained medical professionals such as radiologist and dentist.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K202116

Reference Device(s)

K131616, K150761, K161246, K163539, K173863, K190791, K200178

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Summary

October 4, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Ewoosoft Co., Ltd. % Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Karman Ave., STE 160 IRVINE CA 92612

Re: K211795

Trade/Device Name: EzDent-i/ E2/ Prora View/ Smart M Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: August 10, 2021 Received: August 13, 2021

Dear Ms. 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); medical device reporting of medical device-related adverse events) (21 CFR 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

Indications for Use

510(k) Number (if known) K211795

Device Name EzDent-i / E2 / Prora View / Smart M Viewer

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary (K211795)

This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.

1. Date: 8/10/2021

2. Applicant / Submitter

Ewoosoft Co., Ltd. 801-ho, Vatechnetworks Bldg., 13, Samsung 1-ro 2-gil, Hwaseong-si. Gyeonggido . Republic of Korea Fax: +82 31 8015 6196 Tel: +82 31 8015 6172 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. Subject Device:

Trade/Device Name: EzDent-i / E2 / Prora View / Smart M Viewer
. Regulation Number: 21 CFR 892.2050
Regulation Name: Medical Image Management and Processing System ●
Regulatory Class: Class II ●
Product Code: LLZ ●

5. Predicate Device:

Manufacturer: Ewoosoft Co., Ltd. ●
Trade/Device Name: EzDent-i v3.1
510k Number: K202116 ●
Regulation Number: 21 CFR 892.2050 ●
Regulation Name: Medical Image Management and Processing System ●
Regulatory Class: Class II ●
Product Code: LLZ

6. Device Description:

7. Indication for use:

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.

8. Substantial Equivalence:

	Modified Device	Unmodified Device
Device name	EzDent-i v3.2	EzDent-i v3.1
510K number	K211795	K202116
Manufacturer	Ewoosoft	Ewoosoft
Indications for use	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 and save 2D
image files, load DICOM project files
from panorama, cephalometric, and
intra-oral imaging equipment.	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 and save 2D
image files, load DICOM project files
from panorama, cephalometric, and
intra-oral imaging equipment.
	Technology/Principle
of Operation	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.
EzDent-i supports general image
formats such as JPG and BMP for 2D
image viewing as well as DICOM
format.
EzDent-i supports the acquisition of
dental images by interfacing with
OpenCV library to import the intra-
oral camera images. It also supports
the acquisition of
CT/Panoramic/Cephalo/Intra-Oral
Sensor images by interfacing with X-
ray capture software.	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.
EzDent-i supports general image
formats such as JPG and BMP for 2D
image viewing as well as DICOM
format.
EzDent-i supports the acquisition of
dental images by interfacing with
OpenCV library to import the intra-
oral camera images. It also supports
the acquisition of
CT/Panoramic/Cephalo/Intra-Oral
Sensor images by interfacing with X-
ray capture software.
		Platform	IBM-compatible PC or PC network	IBM-compatible PC or PC network
		Operating System	Microsoft Windows XP, Vista, 7, 8,10	Microsoft Windows XP, Vista, 7, 8,10
		User Interface	Mouse, Keyboard	Mouse, Keyboard
		Image Input Sources	Images can be scanned, loaded from
digital cameras or card readers, or
imported from a radiographic imaging
device	Images can be scanned, loaded from
digital cameras or card readers, or
imported from a radiographic imaging
device
			32 bit / 64 bit	32 / 64 bit	32 / 64 bit
			Image format	DICOM	DICOM
			Patient Database	SQL	SQL
		Includes Image
Measurement tools	Linear distance, angle	Linear distance, angle
		Image viewing	Full, side by side, gallery, thumbnail	Full, side by side, gallery, thumbnail
		Image manipulation	Brightness, contrast, sharpness, inverse, film view, rotate, zooming, whitening, nerve canal tracing, memo	Brightness, contrast, sharpness, inverse, film view, rotate, zooming, whitening, nerve canal tracing, memo
		Implant module	Generic implant libraries	Generic implant libraries
		3D imaging
capability	Includes interface to 3D imaging software, Ez3D-i. EzDent-i imaging software does not view, transfer or process 3D radiographs.	Includes interface to 3D imaging software, Ez3D-i. EzDent-i imaging software does not view, transfer or process 3D radiographs.
		Image annotation	Text, paint, ellipse, pointer, select, draw, magnify, line, rectangle, polygon, ruler, protractor, smile library, smudge, brush, redeye reduction, select region, copy / paste	Text, paint, ellipse, pointer, select, draw, magnify, line, rectangle, polygon, ruler, protractor, smile library, smudge, brush, redeye reduction, select region, copy / paste

EzDent-i v3.2 described in this 510(k) has the same intended use and the same technical characteristics as the unmodified device.

The subject device and the unmodified device are substantially equivalent, having the same indications for use and functionalities like operation software, computer platform, picture archiving and communication format, image format, image processing features, windowing, image edit, measurements and manipulation.

The modifications are PC system requirement information change, adding logout option, and upgrades to Setting tab, Viewer tab, and Report tab. These differences are not significant since they are additional features for user convenience and do not raise the questions of safety or effectiveness. Based on the test results submitted in this 510K, we conclude that the subject device is substantially equivalent to the predicate device.

9. Technological Characteristics:

EzDent-i v3.2 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:

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.