Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard computer-processed image reconstruction for CT imaging and does not mention AI or ML.

Therapeutic

No.
The device is described as an X-ray imaging device used for diagnostic purposes, not for treatment.

Diagnostic

Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The DENTRIa series is a Computed Tomography X-Ray imaging device specialized in diagnosing general dental treatments and orthodontic purpose," and the "Device Description" states it is "used for diagnostic purpose in dental treatment."

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components like an X-ray generator, detector, and rotating arm, indicating it is a physical imaging device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
Device Function: The description clearly states that this device is a Computed Tomography X-Ray imaging device. It works by generating X-rays that pass through the patient's body and are detected to create images of internal structures. This is an in vivo (within the living body) imaging technique, not an in vitro (outside the living body) diagnostic test.
Intended Use: The intended use is for diagnosing conditions using images of the head and neck areas, not by analyzing biological samples.

Therefore, while it is a diagnostic device, it falls under the category of medical imaging devices, not In Vitro Diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The DENTRIa series is a Computed Tomography X-Ray imaging device specialized in diagnosing general dental treatments and orthodontic purpose using Panoramic and Cephalometric images respectively. In addition DENTRIC series is used in the field of Otolaryngology by capturing 360 degree rotation sequence of the head and neck areas, including the ENT and dentomaxillofacial areas for a dental treatment in adult and pediatric dentistry and obtains x-ray images from different angles and calculate through computer-processed to produce 3D x-ray tomographic images. The DENTRIC series used by physicians, dentists, and x-ray technologists.

Product codes (comma separated list FDA assigned to the subject device)

OAS

Device Description

This Equipment is a Dental X-Ray imaging device used for diagnostic purpose in dental treatment. The operating principle of this device is obtaining the tomographic, and panoramic images by rotating arm to get the recombination data. X-ray generator and detector rotate around the patient to irradiate the X-ray, and penetrated X-ray is measured by the detector. When the X-ray is irradiated on the teeth area for instance, large amount of X-ray is attenuated because objects such as bones are highly dense. On the contrast, X-ray is more permeable to small molecules with low density such as skin or tissue, so more X-ray would pass through the subject. By measuring data obtained from measuring the X-ray is reconstructed by the software to display and analyze the anatomical structure for the diagnosis purposes.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Computed Tomography X-Ray

Anatomical Site

head and neck areas, including the ENT and dentomaxillofacial areas

Indicated Patient Age Range

adult and pediatric

Intended User / Care Setting

physicians, dentists, and x-ray technologists.

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)

Bench testing was used to assess whether the parameter measured required for describing functionalities related to the dental X-ray device's imaging properties meet the criteria under the designated tolerance. Image performance testing was conducted according to IEC 61223-3-4 standard. The test results show that the DENTRIa series met all requirements of the standard. Non-clinical performance was conducted for imaging performance of the proposed detector in accordance with FDA guidance: "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices, issued on September 1, 2016". MTF (Modulation Transfer Function) and DQE (Detective Quantum Efficiency) were tested, measured, and compared with the detectors of the predicate devices in terms of detector type, pixel size, active area, MTF and DQE, the diagnostic image quality of the detector is equal or better than those of the predicate devices based on the Non-clinical test results. Therefore, there are no significant differences in the safety and performance of the detectors.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K160140

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

0

October 19, 2021

Image /page/0/Picture/1 description: The image contains 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.

HDX Will Corp. % Kaon Kim Junior Manager, Regulatory Affairs #105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong 4-ro Osong-eup. Heungdeok-gu Cheongju-si, Chungcheongbuk-do 28161 REPUBLIC OF KOREA

Re: K212254

Trade/Device Name: DENTRIa series (DENTRIα, DENTRI-Cα, DENTRI-Sα) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: July 20, 2021 Received: July 22, 2021

Dear Kaon Kim:

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

1

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 (OS) 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) K212254

Device Name DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)

Indications for Use (Describe)

The DENTRIa series is a Computed Tomography X-Ray imaging device specialized in diagnosing general dental treatments and orthodontic purpose using Panoramic and Cephalometric images respectively. In addition DENTRIC series is used in the field of Otolaryngology by capturing 360 degree rotation sequence of the head and neck areas, including the ENT and dentomaxillofacial areas for a dental treatment in adult and pediatric dentistry and obtains x-ray images from different angles and calculate through computer-processed to produce 3D x-ray tomographic images. The DENTRIC series used by physicians, dentists, and x-ray technologists.

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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3

510(k) Summary

[As required by 21 CFR 807.92]

1. Date Prepared [21 CFR 807.92(a)(1)]

October 14th, 2021

2. Submitter's Information [21 CFR 807.92(a)(1)]

- Name of Manufacturer:	HDX WILL Corp.
- Address:	#105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong
4-ro, Osong-eup, Heungdeok-gu, Cheongju-si,
Chungcheongbuk-do, 28161, Republic of Korea
- Contact Person:	Kaon Kim / Junior Manager
- Telephone No.:	+82-43-710-7318
- Fax No.:	+82-43-710-7312
- Email Address:	kaonkim@iwillmed.com
- Registration No.:	3013511605

3. Trade Name, Regulation Name, Classification [21 CFR 807.92(a)(2)]

| Device Name | DENTRIa series
(DENTRIa, DENTRI-Ca, DENTRI-Sa) |
|---------------------|---------------------------------------------------|
| Regulation Number | 21 CFR 892.1750 |
| Regulation Name | Computed tomography x-ray system |
| Common/Usual Name | Dental X-ray System |
| Regulatory Class | Class II |
| Product Code | OAS |
| Classification Name | X-Ray, Tomography, Computed, Dental |
| Panel | Radiology |

4

4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]

The identified predicate devices within this submission are shown as follow;

Predicate device

- 510(k) Number:	K160140
- Applicant:	HDX WILL Corp.
- Device Name:	DENTRIα series (DENTRIα, DENTRI-Cα, DENTRI-Sα)
- Regulation Number:	21 CFR 892.1750
- Regulation Name:	Computed tomography x-ray system
- Regulatory Class:	Class II
- Product Code:	OAS
- Classification Name:	X-Ray, Tomography, Computed, Dental

There are no significant differences between the DENTRIa series and the predicate device that would adversely affect the use of the product. It is substantially equivalent to these devices in technical characteristics, output characteristics and operation mode.

5. Description of the Device [21 CFR 807.92(a)(4)]

This Equipment is a Dental X-Ray imaging device used for diagnostic purpose in dental treatment. The operating principle of this device is obtaining the tomographic, and panoramic images by rotating arm to get the recombination data. X-ray generator and detector rotate around the patient to irradiate the X-ray, and penetrated X-ray is measured by the detector. When the X-ray is irradiated on the teeth area for instance, large amount of X-ray is attenuated because objects such as bones are highly dense. On the contrast, X-ray is more permeable to small molecules with low density such as skin or tissue, so more X-ray would pass through the subject. By measuring data obtained from measuring the X-ray is reconstructed by the software to display and analyze the anatomical structure for the diagnosis purposes.

5

1) The DENTRIα series is classified as shown below:

DENTRIα: CT Mode + Panorama Mode + Model Scan Mode

DENTRI-Cα: CT Mode + Panorama Mode + Model Scan Mode + Cephalo Mode (One-shot) DENTRI-Sα: CT Mode + Panorama Mode + Model Scan Mode + Cephalo Mode (Scan)

| MODEL | CT | Panorama | Cephalo
One-shot | Cephalo
Scan | Model Scan
(Optional) | Cu Filter
(Optional) |
|-------------------------------------|----|----------|---------------------|-----------------|--------------------------|-------------------------|
| DENTRIα
Stitch
(Option) | ● | ● | - | - | ● | ● |
| DENTRIα
Non-Stitch
(Option) | ● | ● | - | - | ● | ● |
| DENTRI-Cα
Stitch
(Option) | ● | ● | ● | - | ● | ● |
| DENTRI-Cα
Non-Stitch
(Option) | ● | ● | ● | - | ● | ● |
| DENTRI-Sα
Stitch
(Option) | ● | ● | - | ● | ● | ● |
| DENTRI-Sα
Non-Stitch
(Option) | ● | ● | - | ● | ● | ● |

2) Description of the image detectors used.

Model	DENTRIα, DENTRI-Ca, DENTRI-Sα	DENTRI-Ca	DENTRI-Sα
Contents	CT / Panorama/ Model Scan	Cephalo
(One-shot type)	Cephalo
(Scan type)
Detector
model	Xineos-1313
(Optional)	FLAATZ 330N	Xineos-2301 /
Xineos-2301S
Manufacturer	Teledyne DALSA	DR Tech	Teledyne DALSA
Detector type	CMOS
(Complementary
metal oxide
semiconductor)	TFT: a-Se (Thin-
Film Transistor,
Amorphous
Selenium)	CMOS
(Complementary
metal oxide
semiconductor)
Resolution
(pixels)	1316 x 1312	2048 x 1536	2304 x 68
Pixel size
(um)	100.1	129.0	99.0
MTF	57% at 1 lp/mm	83.3% at 2 lp/mm	65% at 1 lp/mm
DQE	70% at 0 lp/mm	38.5% at 0 lp/mm	57% at 1 lp/mm
Active area
(mm)	131 x 131	198 x 264	228 x 6.7
A/D
Conversion	14 bits	14 bits	14 bits
FDA 510(k)
number	Not Known	Not Known	Not Known
510(k)
cleared
device
including
corresponding
detector as a
component	1) System name:
DENTRIα,
DENTRI-Ca,
DENTRI-Sα

Manufacturer:
HDX WILL Corp.
510(k)
number:
K160140 | 1) System name:
DENTRIα,
DENTRI-Ca,
DENTRI-Sα
Manufacturer:
HDX WILL Corp.
510(k) number:
K160140 | Xineos-2301:
System name:
DENTIOIII,
DENTIOIII-S
Manufacturer:
HDX WILL Corp.
510(k) number:
K181297
Xineos-2301S: Not
known |
| | TFT: a-Si (Thin-
Film Transistor,
Amorphous
Silicon) | | |
| | 1) System name:
RCT800
Manufacturer:
Ray Co., Ltd.
510(k)
number:
K192737 | | |

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6. Indications for Use [21 CFR 807.92(a)(5)]

The DENTRIα series is a Computed Tomography X-Ray imaging device specialized in diagnosing general dental treatments and orthodontic purpose using Panoramic and Cephalometric images respectively. In addition DENTRIα series is used in the field of Otolaryngology by capturing 360 degree rotation sequence of the head and neck areas, including the ENT and dentomaxillofacial areas for a dental treatment in adult and pediatric dentistry and obtains x-ray images from different angles and calculate through computer-processed to produce 3D x-ray tomographic images. The DENTRIα series used by physicians, dentists, and x-ray technologists.

7

7. Determination of Substantial Equivalence

Summary of technological characteristics of the device compared to the predicate device. [21 CFR 807.92(a)(6)]

Applicant	HDX WILL Corp.	HDX WILL Corp.	SE Note
Device Name	DENTRIα series
(DENTRIα, DENTRI-Ca, DENTRI-Sa)	DENTRIα series
(DENTRIα, DENTRI-Ca, DENTRI-Sa)
	Subject Device	Predicate Device	-
510(k) Number	K212254	K160140	-
Common/Usual
Name	Dental X-ray System	Dental X-ray System	-
Regulation
Number	892.1750	892.1750	-
Product Code	OAS	OAS	-
Class	Class II	Class II	-
Model	DENTRIα, DENTRI-Ca, DENTRI-Sa	DENTRIα, DENTRI-Ca, DENTRI-Sa	-
Indications for
Use	The DENTRIα series is a Computed
Tomography X-Ray imaging device
specialized in diagnosing general
dental treatments and orthodontic
purpose using Panoramic and
Cephalometric images respectively. In
addition DENTRIα series is used in the
field of Otolaryngology by capturing 360
degree rotation sequence of the head
and neck areas, including the ENT and
dentomaxillofacial areas for a dental
treatment in adult and pediatric
dentistry and obtains x-ray images from
different angles and calculate through
computer-processed to produce 3D x-
ray tomographic images. The DENTRIα
series used by physicians, dentists, and
x-ray technologists.	The DENTRIα series is a Computed
Tomography X-Ray imaging device
specialized in diagnosing general
dental treatments and orthodontic
purpose using Panoramic and
Cephalometric images respectively. In
addition DENTRIα series is used in the
field of Otolaryngology by capturing 360
degree rotation sequence of the head
and neck areas, including the ENT and
dentomaxillofacial areas for a dental
treatment in adult and pediatric
dentistry and obtains x-ray images from
different angles and calculate through
computer-processed to produce 3D x-
ray tomographic images. The DENTRIα
series used by physicians, dentists, and
x-ray technologists.	Same
Operation Mode	1. CT

Panorama
Cephalo

One-Shot type
Scan type

Model Scan | 1. CT
Panorama
Cephalo

One-Shot type
Scan type | Similar | |
| X-ray tube assembly | | | | |
| X-ray tube
assembly
options | PXD-140CT
(Optional) | WDG90
(Optional) | - | |
| X-ray tube | OPX/105 (C.E.I.) | OX/115-05 (C.E.I.) | Similar | |
| Target angle | 5° | 15° | Similar | |
| Focal spot size
according to IEC
60336, measured | 0.5 mm | 0.5 mm | Same | |
| Inherent filtration
according to IEC 60522 | 0.5 mmAl | 0.5 mmAl | 0.5 mmAl | Same |
| Anode material | Tungsten | Tungsten | Tungsten | Same |
| Total filtration of
X-ray tube
assembly | > 2.5 mmAl | > 2.5 mmAl + 0.5 mmCu (Optional) | > 2.5 mmAl | Similar |
| Range of X-ray
Tube Voltage
settings | PXD-140CT
(Optional)

CT
60-110 kV ±8%
Panorama
60-90 kV ±8%
Cephalo

One-Shot type
60-110 kV ±8%
Scan type
60-90 kV ±8% | WDG90 (Optional)

CT
60-90 kV ±8%
Panorama
60-90 kV ±8%
Cephalo

One-Shot type
60-90 kV ±8%
Scan type
60-90 kV ±8% | 1. CT
60-110 kV ±8%

Panorama
60-90 kV ±8%
Cephalo

One-Shot type
60-110 kV ±8%
Scan type
60-90 kV ±8% | Same |
| Range of X-ray
Tube Current
settings | 4-10 mA ±10% | 4-10 mA ±10% | 4-10 mA ±10% | Same |
| Range of
Irradiation Time
settings | 1. CT
8.0-36.0 s ± (5 % + 50 ms)

Panorama
1.2-14.0 s ± (5 % + 50 ms)
Cephalo

One-Shot type
0.5 s to 2.0 s ± (5 % + 50 ms) (in 0.5 s
increments)
Scan type
2.5-8.0 s ± (5 % + 50 ms)

Model Scan
24 s | 1. CT(Normal)
8 s or 24 s ± 10 %
Panorama
14 s and less ± 10 %
Cephalo

One shot type
0.5, 1, 1.5, 2 s ± 10 %
Scan type
8.2 s and less ± 10 % | | Similar |
| Image Properties | | | | |
| Detector type | 1. CT
CMOS or TFT:a-Si

Panorama
CMOS or TFT:a-Si
Cephalo

One-shot type
TFT:a-Se
Scan type
CMOS | 1. CT
Flat panel

Panorama
Flat panel
Cephalo

One shot type
Flat panel
Scan type
CCD | | Similar |
| Pixel size | 1. CT
100.1 um or 119 um

Panorama
100.1 um or 119 um
Cephalo

One-shot type
129.0 um
Scan type
99.0 um | 1. CT:
100.1 or 127 μm

Panorama:
100.1 or 127 μm
Cephalo

One shot type:
129 μm
Scan type:
27 μm | | Similar |
| Active area
(mm) | 1. CT
131 x 131 or
149.464 x 149.464

Panorama
6 x 130 or | 1. CT:
131 x 131 mm or
130 x 130 mm
Panorama:
6 x 131 mm or | | Similar |
| | | | | |
| | 6 x 149.5 | 3.94 x 128.78 mm | | |
| | 3. Cephalo | 3. Cephalo | | |
| | 1) One-shot type | 1) One shot type: | | |
| | 198 x 264 | 193 x 259 mm | | |
| | 2) Scan type | 2) Scan type: | | |
| | 6.7 x 228 | 6.9 x 221 mm | | |
| | 1. CT: | 1. CT: | | |
| | - 57% at 1 lp/mm or | - 57% at 1 Lp/mm or | | |
| | - 60% at 1 lp/mm | - 55% at 1 Lp/mm | | |
| | 2. Panorama: | 2. Panorama: | | |
| MTF | - 57% at 1 lp/mm or

60% at 1 lp/mm | - 57% at 1 Lp/mm or
55% at 1 Lp/mm | Similar | |
| | 3. Cephalo | 3. Cephalo | | |
| | 1) One shot type | 1) One shot type: | | |
| | - 83.3% at 2 lp/mm | - 83.3% at 2 Lp/mm | | |
| | 2) Scan type: | 2) Scan type: | | |
| | - 65% at 1 lp/mm | - 70% at 1 Lp/mm | | |
| | 1. CT: | 1. CT: | | |
| | - 70% at 0 lp/mm or
60% at 1 lp/mm | - 70% at 0 Lp/mm or
58% at 1 Lp/mm | | |
| | 2. Panorama: | 2. Panorama: | | |
| DQE | - 70% at 0 lp/mm or
60% at 1 lp/mm | - 70% at 0 Lp/mm or
58% at 1 Lp/mm | Similar | |
| | 3. Cephalo | 3. Cephalo | | |
| | 1) One shot type | 1) One shot type: | | |
| | - 38.5% at 0 lp/mm | - 38.5% at 0 Lp/mm | | |
| | 2) Scan type: | 2) Scan type: | | |
| | - 57% at 1 lp/mm | - 50% at 0 Lp/mm | | |
| | | | | |
| Geometry | | | | |
| | 1. CT | 1. CT | | |
| | 600 mm | 600 mm | | |
| | 2. Pano | 2. Panorama | | |
| Source Image
Distance
(SID) | 560 mm | 560 mm | Similar | |
| | 3. Cephalo | 3. Cephalo | | |
| | 1) One-Shot Ceph
1792 mm | 1) One shot type
1790 mm | | |
| | 2) Scan Ceph
1,782 mm | 2) Scan type
1783 mm | | |
| Format
Compatible | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible | Same | |

a) Technological Characteristics

in the central Xray beam

8

9

HDX WILL Corp.

Image /page/9/Picture/1 description: The image contains a logo for HDX Will. The logo features a green and blue square with a white "W" inside, followed by the text "HDX Will" in a bold, blue font. The text is slightly slanted to the right, giving the logo a dynamic appearance.

05, 106, 201, 202, 203, 204, 38, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongiu-si. Chunacheongbuk-do. 28161. Republic of Korea TEL: +82=43-710-7318 FAX: +82-43-710-7312

b) Substantial Equivalence Discussion

The DENTRIα series is substantially equivalent to the predicate device identified above with respect to intended use, principles of operation, and technological characteristics. From the information provided in table above, it is understood that the subject device does not introduce any new technology and/or indications of use. Therefore, the DENTRIα series is considered substantially equivalent to the predicate device.

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8. Non-Clinical Test Summary

The DENTRIa series is verified and validated according to the FDA design control requirements, 21 CFR 820. The subject device had been subjected to the applicable safety and performance testing before release to ensure the device meets all its specifications. The quality assurance measures applied to the design and development of the subject device include, but not limited to risk analysis, verification and validation, product specifications and design reviews.

1) Thermal, electrical, mechanical safety & Electromagnetic Compatibility

The DENTRIa series complies with the electrical safety and electromagnetic compatibility requirements established by the standards below:

Electrical Basic Safety and Essential Performance requirements in accordance with ES60601-1
Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2
Radiation Protection In diagnostic X-Ray Equipment requirements of IEC 60601-1-3
Dental Extra-Oral X-Ray Equipment requirements of IEC 60601-2-63

The manufacturing facility is in conformance with the relevant EPRC standards as specified in 21 CFR 1020.30, and 1020.31. The records are available for review.

2) Software Validations

The DENTRIa series utilizes original software and OTS software as an image viewer. The DENTRIα series contains MODERATE level of concern software. Software was designed and developed according to a software development process and was verified and validated.

The algorithm type of image reconstruction is FBP (Filtered Back Projection).

Software information is provided in accordance with FDA guidance: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2005."

Cybersecurity information is provided in accordance with FDA guidance: "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, issued on October 2, 2014"

3) Biocompatibility

A biocompatibility test is not necessary when considering the device's characteristics.

4) Performance Test

Bench testing was used to assess whether the parameter measured required for describing functionalities related to the dental X-ray device's imaging properties meet the criteria under the designated tolerance.

lmage performance testing was conducted according to IEC 61223-3-4 standard. The test results show that the DENTRIα series met all requirements of the standard.

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5) SSXI (Solid State X-ray Imaging) Devices Report

Non-clinical performance was conducted for imaging performance of the proposed detector in accordance with FDA guidance: "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices, issued on September 1, 2016". MTF (Modulation Transfer Function) and DQE (Detective Quantum Efficiency) were tested, measured, and compared with the detectors of the predicate devices in terms of detector type, pixel size, active area, MTF and DQE, the diagnostic image quality of the detector is equal or better than those of the predicate devices based on the Non-clinical test results. Therefore, there are no significant differences in the safety and performance of the detectors.

9. Conclusion [21 CFR 807.92(b)(3)]

In conclusion, the conducted tests, as well as all verification and validation activities, demonstrate that the design specifications and technological characteristics of the DENTRIα series meet applicable requirements and standards for its safety and effectiveness for the intended use. The testing and validation activities conducted demonstrate that any differences between the subject device and the predicate devices do not raise new or different questions of safety or effectiveness compared to the predicate devices. Therefore, the DENTRIα series is substantially equivalent to the predicate devices.