Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard computer-processed reconstruction of tomographic images (FBP) and does not mention any AI/ML techniques or algorithms.

Therapeutic

No
Explanation: The device is explicitly described as an "X-Ray imaging device used for diagnostic purpose." It produces images to help diagnose conditions, but it does not treat them.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is "specialized in diagnosing general dental treatments and orthodontic purpose" and "obtains x-ray images from different angles and calculate though computer-processed to produce 3D x-ray tomographic images." The "Device Description" also clearly indicates it is "a Dental X-Ray imaging device used for diagnostic purpose in dental treatment" and "reconstructed by the software to display and analyze the anatomical structure for the diagnosis purposes."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Dental X-Ray imaging device" and describes hardware components like a rotating arm, X-ray generator, and detector. While it uses software for image reconstruction, it is fundamentally a hardware device that utilizes software.

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 (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
Device Function: The DENTRIα series is an imaging device that uses X-rays to create images of the internal structures of the head and neck. It does not analyze biological specimens.
Intended Use: The intended use is for diagnosing conditions based on the visual information provided by the X-ray images.

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

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 though computer-processed to produce 3D x-ray tomographic images. The DENTRIα series is 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 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-rav is reconstructed by the software to display and analyze the anatomical structure for the diagnosis purposes.

The DENTRIα Series are classified as shown below.

DENTRIa: CT Mode + PANORAMA Mode DENTRI-Ca: CT Mode + PANORAMA Mode + CEPHALO Mode (ONE-SHOT) DENTRI-Sa: CT Mode + PANORAMA Mode + CEPHALO Mode (SCAN)

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Computed Tomography X-Ray, Panoramic X-Ray, Cephalometric X-Ray

Anatomical Site

head and neck areas, including the ENT and dentomaxillofacial areas

Indicated Patient Age Range

adult and pediatric dentistry

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)

Non-Clinical Test Summary:

Electrical Safety, Electromagnetic Compatibility and Performance: The DENTRIα series complies with the electrical safety and electromagnetic compatibility requirements established by the standards AAMI ES60601-1 and IEC 60601-1-2. Bench testing of the subject devices includes: Testing to confirm compliance with the Basic Safety and Essential Performance requirements of AAMI ES60601-1, Testing to confirm compliance with EMC requirements of IEC 60601-1-2, Testing to confirm compliance with Radiation Protection In Diagnostic X-Ray Equipment requirements of IEC 60601-1-3, Testing to confirm compliance with Dental Extra-Oral X-Ray Equipment requirements of IEC 60601-2-63, Testing to confirm compliance with Acceptance Tests Imaging Performance Of Dental X-Ray requirements of IEC 61223-3-4.
Software Validation: The DENTRIα series use 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 type of reconstruction is FBP.
Biocompatibility: A biocompatibility study is not necessary and proper device disinfection is sufficient to address any health concerns.
SSXI Report: Non-clinical performance was conducted for imaging performance of the proposed detector in accordance with FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices".

Clinical Test Summary: The clinical images of patients are presented as the clinical data including date and signature by a licensed professional. The report concluded that the images taken with the subject device are of good diagnostic quality.

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.

K093590, K142247

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 30, 2016

HDX WILL CORP. % Mr. Hyung-Suk Oh General Manager #105,201,202,203,204,38 Osongsaengmyeong 4-ro, Osong-eup Heungdeok-gu Cheongju-si, Chungcheongbuk-do 28161 REPUBLIC OF KOREA

Re: K160140

Trade/Device Name: DENTRIa series (DENTRIq, DENTRI-Ca, DENTRI-Sa) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: September 2, 2016 Received: September 6, 2016

Dear Mr. Oh:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/0 description: The image contains the logo for HDX Will. The logo features a green square with a white "W" inside on the left. To the right of the square is the text "HDX Will" in blue, with the "Will" portion of the name in a stylized font.

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use

	Form Approved: OMB No. 0910-0120
	Expiration Date: January 31, 2017
See PRA Statement below.

510(k) Number (if known)	K160140
Device Name	DENTRIα series (DENTRIα, DENTRI-Cα, DENTRI-Sα)
Indications for Use (Describe)	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 though computer-processed to produce 3D x-ray tomographic images. The DENTRIα series is used by physicians, dentists, and x-ray technologists.

510(k) Number (if known)

K160140

Device Name

DENTRIα series (DENTRIα, DENTRI-Cα, DENTRI-Sα)

Indications for Use (Describe)

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 though computer-processed to produce 3D x-ray tomographic images. The DENTRIα series is 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)

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."

FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Servios (301) 443-6740 EF

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510(k) Summary

[As required by 21 CFR 807.92]

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

September 02, 2016

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

- Name of Manufacturer:	HDX WILL CORP.
- Address:	#105, 201, 202, 203, 204, 38, Osongsaengmyeong 4-ro,
Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do,
28161, Korea
- Contact Name:	Hyung-suk Oh/ General Manager
- Telephone No.:	+82-43-710-7318
- Fax No.:	+82-43-710-7312
- Email Address:	wrcohs@iwillmed.com
- Registration No.:	In process

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

Trade Name	DENTRIα series (DENTRIα, DENTRI-Cα, DENTRI-Sα)
Regulation Name	Computed tomography x-ray system
Classification Panel	Radiology
Classification Regulation	21 CFR 892.1750
Product Code	OAS
Device Class	II

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Image /page/4/Picture/0 description: The image shows the logo for HDX Will. The logo consists of a green square with a white "W" inside, followed by the text "HDX Will" in blue. The text is in a bold, sans-serif font and is slightly larger than the square with the "W".

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 #1

510(k) Number: K093590 -
Applicant: PLANMECA OY -
Regulation Name: Extraoral source x-ray system -
-Product Code: MUH
Class II Device Class: -
Device Name: PLANMECA PROMAX 3D MAX -

Predicate device #2

510(k) Number:	K142247
Applicant:	RAY Co.,Ltd
Regulation Name:	Computed tomography x-ray system
Product Code:	OAS
Device Class:	Class II
Device Name:	RAYSCANα-Expert 3D

There are no significant differences between the DENTRIα series (DENTRIα, DENTRI-Cα, DENTRI-Sa) 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.

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

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 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-rav is reconstructed by the software to display and analyze the anatomical structure for the diagnosis purposes.

The DENTRIα Series are classified as shown below.

DENTRIa: CT Mode + PANORAMA Mode DENTRI-Ca: CT Mode + PANORAMA Mode + CEPHALO Mode (ONE-SHOT) DENTRI-Sa: CT Mode + PANORAMA Mode + CEPHALO Mode (SCAN)

General Information

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Image /page/5/Picture/0 description: The image features the logo for HDX Will, with a green square containing a white "W" on the left. To the right of the square, the text "HDX Will" is displayed in a bold, blue font. The logo appears to be professionally designed and is likely used for branding purposes.

1. Description of the image detectors used.

CT detector

| | Proposed Device | | Predicate
Device #1 | Predicate Device
#2 |
|------------------------|-------------------------------|---------------------------|------------------------|------------------------|
| Model | DENTRIα, DENTRI-Cα, DENTRI-Sα | | PROMAX 3D
MAX | RAYSCAN α-
Expert3D |
| Contents | CT detector (option) | | 3D detector | CT detector |
| Detector model | Xineos-1313 | PaxScan1313DX | Not known | C10900D |
| Manufacturer | Teledyne DALSA | Varian Medical
Systems | Not known | Hamamatsu |
| Detector type | Flat panel
detector | Flat panel
detector | Flat panel
detector | Flat panel
detector |
| Resolution
(pixels) | 1,316 x 1,312 | 1,024 x 1,024 | Not known | 624 × 624 |
| Pixel size (µm) | 100.1 | 127.0 | 127.0 | 200.0 |
| MTF | 57% at 1 LP/mm | 55% at 1 LP/mm | Not known | 60% at 1 LP/mm |
| DQE | 70% at 0 LP/mm | 58% at 1 LP/mm | Not known | 23% at 1 LP/mm |
| Active area
(mm) | 131 x 131 | 130 x 130 | 193 x 242 | 124.8 x 124.8 |
| A/D
Conversion | 14 bits | 16 bits | Not known | 13 bits |
| FDA 510(k)
Number | Not known | Not known | Not known | K122981
(System) |

PANORAMA detector -

Model	Proposed Device		Predicate Device #1	Predicate Device #2
	DENTRIα, DENTRI-Cα, DENTRI-Sα		PROMAX 3D MAX	RAYSCAN α-Expert3D
Contents	PANORAMA detector (option)		Smart Pan detector	PANO detector
Detector model	Xineos-1313	PaxScan1313DX	Not known	C10500D
Manufacturer	Teledyne DALSA	Varian Medical Systems	Not known	Hamamatsu
Detector type	Flat panel detector	Flat panel detector	Flat panel detector	Flat panel detector
Resolution
(pixels)	1,316 x 1,312	1,024 x 1,024	Not known	60 x 1,512

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Image /page/6/Picture/0 description: The image is a logo for HDXWill. The logo features a green and blue design. On the left side of the logo is a green square with a white "W" inside. To the right of the square is the text "HDXWill" in blue.

Model	Proposed Device		Predicate Device #1	Predicate Device #2
	DENTRIα, DENTRI-Cα, DENTRI-Sα		PROMAX 3D MAX	RAYSCAN α-Expert3D
Contents	PANORAMA detector (option)		Smart Pan detector	PANO detector
Pixel size (µm)	100.1	127.0	127.0	100.0
MTF	57% at 1 LP/mm	55% at 1 LP/mm	Not known	70% at 1 LP/mm
DQE	70% at 0 LP/mm	58% at 1 LP/mm	Not known	50% at 1 LP/mm
Active area (mm)	6 x 131	3.94 x 128.78	13 x 162	6 x 148
A/D Conversion	14 bits	16 bits	Not known	14 bits
FDA 510(k) Number	Not known	Not known	Not known	K122981 (System)

CEPHALO detector (ONE-SHOT)

Model	Proposed Device	Predicate Device #1	Predicate Device #2
Contents	DENTRI-Ca	PROMAX 3D MAX	RAYSCAN α-Expert3D
Detector model	CEPHALO (ONE-SHOT)	Planmeca ProCeph	Ceph (One shot, Large
Size) detector
Manufacturer	FLAATZ 330N	Not known	PaxScan 4336X
Detector type	DR Tech	Not known	Varian
Resolution
(pixels)	Flat panel detector	Flat panel detector	Flat panel detector
Pixel size (µm)	2,048 x 1,536	Not known	3,072 x 2,560
MTF	129.0	139.0	139.0
DQE	83.3% at 2 LP/mm	Not known	54% at 1 LP/mm
Active area
(mm)	38.5% at 0 LP/mm	Not known	20% at 1 LP/mm
A/D
Conversion	193 x 259	302 x 249	427 x 356
FDA 510(k)
Number	14 bits	Not known	16 bits
	Not known	Not known	K121513 (System)

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Image /page/7/Picture/0 description: The image shows the logo for HDX Will. The logo features a green square with a white "W" inside, followed by the text "HDX Will" in blue. The text is stylized with a slight italicized effect.

CEPHALO detector (SCAN)

	Proposed Device	Predicate Device #1	Predicate Device #2
Model	DENTRI-Ca	PROMAX 3D MAX	RAYSCAN α-
Expert3D
Contents	CEPHALO (SCAN)	Scanning Ceph	Ceph (Scan) detector
Detector model	Argus-Ceph (DM-20-
08K10)	Not known	XID-C24DS
Manufacturer	Teledyne DALSA	Not known	i3System
Detector type	Scanning detector
(CCD-TDI)	CCD detector	CdTe (Direct type)
Resolution
(pixels)	8160 x 256	Not known	48 x 2400
Pixel size (µm)	27.0	48.0	100.0
MTF	70% at 1 LP/mm	Not known	75% at 1 LP/mm
DQE	50% at 0 LP/mm	Not known	88% at 1 LP/mm
Active area
(mm)	6.9 x 221	6 x 292	4.8 x 240
A/D
Conversion	16 bits	Not known	Not known
FDA 510(k)
Number	K141130 (System)	Not known	K131695 (System)

Information for detector own 510(K) number or system in which it was cleared 510(k) number.

Contents	Model	Own 510(K) number	System in which it was cleared 510(k) number.
CEPHALO detector (SCAN)	Argus-Ceph (DM-20-08K10)	No	1) System name: ENCOMPASS HF100

Manufacturer: Panoramic Corp.
510(K) Number: K141130 |

The DENTRIα series has been communicated with the Workstation for the transmission of data using Ethernet cable and RS232 Cable. The CBCT system of DENTRIα series has not a wireless option for the transmission of data

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Image /page/8/Picture/0 description: The image shows the logo for HDX Will. The logo consists of a green square with a white "W" inside, followed by the text "HDX Will" in blue. The text is in a bold, sans-serif font. The logo is simple and modern, and the colors are bright and eye-catching.

1. Laser
  The laser is used for patient positioning and is classified as Class A. This technical characteristic is as follows:
1. Optical output : 1mW or less
1. Wavelength : 655nm
1. Line type : Accurate Straight
1. Form of beam output : Gaussian

6. Intended 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 though computer-processed to produce 3D x-ray tomographic images. The DENTRIα series is used by physicians, dentists, and x-ray technologists.

7. Technological Characteristics [21 CFR 807.92(a)(6)]

Non-Clinical Test Summarv

1. Electrical Safety, Electromagnetic Compatibility and Performance:
  The DENTRIα series complies with the electrical safety and electromagnetic compatibility requirements established by the standards AAMI ES60601-1 and IEC 60601-1-2.

Bench testing of the subject devices includes:

Testing to confirm compliance with the Basic Safety and Essential Performance requirements of AAMI ES60601-1
Testing to confirm compliance with EMC requirements of IEC 60601-1-2
Testing to confirm compliance with Radiation Protection In Diagnostic X-Ray Equipment requirements of IEC 60601-1-3
Testing to confirm compliance with Dental Extra-Oral X-Ray Equipment requirements of IEC 60601-2-63
Testing to confirm compliance with Acceptance Tests Imaging Performance Of Dental ● X-Ray requirements of IEC 61223-3-4

The manufacturing facility is in conformance with the relevant EPRC standards as specified in 21 CFR 1020.30, 31, and 33 and the records are available for review.

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Image /page/9/Picture/0 description: The image shows the logo for HDX Will. The logo consists of a green square with a white "W" inside, followed by the text "HDX Will" in blue. The text is in a bold, sans-serif font.

1. Software Validation
  The DENTRIα series use 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 type of reconstruction is FBP.

Software information is provided in accordance with FDA guidance: "The content of premarket submissions for software contained in medical devices, on May 11, 2005."

1. Biocompatibility
  A biocompatibility study is not necessary and proper device disinfection is sufficient to address any health concerns.
1. SSXI Report
  Non-clinical performance was conducted for imaging performance of the proposed detector in accordance with FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices".

Clinical Test Summary

The clinical images of patients are presented as the clinical data including date and signature by a licensed professional. The report concluded that the images taken with the subject device are of good diagnostic quality.

Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92] 8.

	Proposed Device	Predicate Device #1	Predicate Device #2	SE note
K Number	K160140	K093590	K142247	-
Model	DENTRIα series
(DENTRIα, DENTRI-Cα, DENTRI-Sα)	PLANMECA PROMAX
3D MAX	RAYSCANα-Expert 3D	-
Manufacturer	HDX WILL CORP.	PLANMECA OY	RAY Co.,Ltd	-
Intended 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	PLANMECA PROMAX
3D MAX is a three
dimensional Cone
Beam Volumetric
Tomography (CBVT)
x-ray system, which
is intended to
produce three-
dimensional images
of the human teeth,
jaw and skull. The	RAYSCAN α-Expert
3D, panoramic x-ray
imaging system with
cephalostat, is an
extraoral source x-ray
system, which is
intended for dental
radiographic
examination of the
teeth, jaw, and oral
structures, specifically	Similar
	Proposed Device	Predicate Device #1	Predicate Device #2	SE note
	addition DENTRIα	device uses cone	for panoramic
	series is used in the	shaped x-ray beam	examinations and
	field of Otolaryngology	projected on to a flat	implantology and for
	by capturing 360	panel detector, and	TMJ studies and
	degree rotation	the examined	cephalometry, and it
	sequence of the head	volume image is	has the capability,
	and neck areas,	reconstructed to be	using the CBCT
	including the ENT and	viewed in 3D	technique, to generate
	dentomaxillofacial	viewing stations. The	dentomaxillofacial 3D
	areas for a dental	device is to be	images.
	treatment in adult and	operated and used	The device uses cone
	pediatric dentistry ,	by dentists and other	shaped x-ray beam
	and obtains x-ray	legally qualified	projected on to a flat
	images from different	health care	panel detector, and
	angles and calculate	professionals.	the examined volume
	though computer-		image is
	processed to produce		reconstructed to be
	3D x-ray tomographic		viewed in 3D viewing
	images. The DENTRIα		stations.
	series is used by		2D Image is obtained
	physicians, dentists,		using the standard
	and x-ray		narrow beam
	technologists.		technique.
Operation	1) CT	1) 3D	1) CT	Same
Mode	2) Panorama

Cephalo | 2) Smart Pan
Cephalo | 2) Panorama
Cephalo | |
| | · One shot type | · Planmeca
ProCeph | · One shot type | |
| | · Scan type | · Scanning Ceph | · Scan type | |
| X-ray tube assembly | | | | |
| X-ray tube | OPX/105 (C.E.I. X-ray
tube) | Toshiba D-067SB | Not known | |
| Focal spot
size | 0.5 mm | 0.6 mm | 0.5 mm | Same #2 |
| Target
angle | Target angle 5° | Target angle 12° | Target angle 5° | Same #2 |
| Permanent
filtration | 0.5 mmAl (IEC 60522) | Inherent Filtration
At least 0.8 mm Al at
50 kV | Inherent Filtration
At least 0.8 mm | Similar |
| Total
filtration
of X-ray
tube
assembly | > 2.5 mmAl | 1) 3D: > 2.5 mm Al+
0.5 mm Cu
Smart Pan: > 2.5
mm Al
Cephalo: > 2.5 mm
Al | > 2.6 mmAl | Similar |
| | Proposed Device | Predicate Device #1 | Predicate Device #2 | SE note |
| Anode
material | Tungsten | Tungsten | Tungsten | Same |
| range of X-
ray tube
voltage
settings | 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 % | 1) 3D:
60 - 96 kV ± 5 %
Smart Pan:
60 - 84 kV ± 5 %
Cephalo:
60 - 84 kV ± 5 % | 60 - 90kV | Similar |
| range of X-
ray tube
current
settings | 4 - 10mA ± 10 % | 1 - 16 mA ± 10 % | 4 - 17mA | Similar |
| range of
irradiation
time
settings | 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 % | 1) 3D:
3.6 - 24 s ± 10 %
Smart Pan:
10 s ± 10 %
Cephalo:
• Planmeca
ProCeph:
0.1 - 0.8 s ± 10 %
• Scanning Ceph:

Normal: 12 -
18.7s ± 10 %
High Speed: 6.4 -
9.9s ± 10 % | 1) CT: below 14 s

Panorama:
below 14 s
Cephalo
• One shot type:
below 2 s
• Scan type:
below 18 s | Similar |
| Image properties | | | | |
| Detector
type | 1) CT: Flat panel
Panorama: Flat
panel
Cephalo
• One shot type: Flat
panel
• Scan type: CCD | 1) 3D: Flat panel
Smart Pan: Flat
panel
Cephalo:
• Planmeca
ProCeph: Flat
panel
• Scanning Ceph:
CCD | 1) CT: Flat panel
Panorama: Flat
panel
Cephalo
• One shot type:
Flat panel
• Scan type:
CdTe (Direct type) | Similar |
| Pixel size | 1) CT:
100.1 or 127 µm
Panorama:
100.1 or 127 µm
Cephalo | 1) 3D:
127 µm
Smart Pan:
127 µm
Cephalo:
• Planmeca | 1) CT:
200 µm
Panorama:
100 µm
Cephalo | Similar |
| | Proposed Device | Predicate Device #1 | Predicate Device #2 | SE note |
| | 129 μm
• Scan type:
27 μm | ProCeph: 139 μm
• Scanning Ceph:
48 μm | 139 μm
• Scan type:
100 μm | |
| Active area
(mm) | 1) CT:
• 131 x 131 mm or
• 130 x 130 mm
Panorama:
• 6 x 131 mm or
• 3.94 x 128.78 mm
Cephalo
• One shot type:
193 x 259 mm
• Scan type:
6.9 x 221 mm | 1) 3D:
193 x 242 mm
Smart Pan:
13 x 162 mm
Cephalo:
• Planmeca
ProCeph:
302 x 249 mm
• Scanning Ceph:
6 x 292 mm | 1) CT:
124.8 x 124.8 mm
Panorama:
6 x 148 mm
Cephalo
• One shot type:
427 x 356 mm
• Scan type:
4.8 x 240 mm | Similar |
| MTF | 1) CT:
• 57% at 1 LP/mm
or
• 55% at 1 LP/mm
Panorama:
• 57% at 1 LP/mm
or
• 55% at 1 LP/mm
Cephalo
• One shot type:
83.3% at 2 LP/mm
• Scan type:
70% at 1 LP/mm | Not known | 1) CT:
• 60% at 1 LP/mm
Panorama:
• 70% at 1LP/mm
Cephalo
• One shot type:
54% at 1LP/mm
• Scan type:
75% at 1LP/mm | Similar
#2 |
| DQE | 1) CT:
• 70% at 0 LP/mm
or
• 58% at 1 LP/mm
Panorama:
• 70% at 0 LP/mm
or
• 58% at 1 LP/mm
Cephalo
• One shot type:
38.5% at 0 LP/mm
• Scan type:
50% at 0 LP/mm | Not known | 1) CT:
• 23% at 1 LP/mm
Panorama:
• 50% at 1LP/mm
Cephalo
• One shot type:
20% at 1LP/mm
• Scan type:
88 % at 1LP/mm | Similar
#2 |
| Geometry | | | | |
| | Proposed Device | Predicate Device #1 | Predicate Device #2 | SE note |
| Source
Image
Distance
(SID) | 1) CT: 600 mm
Panorama: 560 mm
Cephalo:
• One shot type:
1790 mm
• Scan type:
1783 mm | 1) 3D: 600 mm
Smart Pan:
600 mm
Cephalo: 1700 mm | Not known | Similar
#1 |
| Format
compatible | DICOM 3.0 Format
compatible | DICOM 3.0 Format
compatible | DICOM 3.0 Format
compatible | Same |
| Dose Information | | | | |
| CT Mode
(Xineos-
1313 or
PaxScan131
3DX) | CTDIw = 11.12mGy
At the FOV Ø 10 X 8
90kV, 10mA | CTDIw = 8.34 mGy
At the FOV Ø 10 X 8
96kV, 10mA | CTDIw = 10.61 mGy
At the FOV Ø 9 X 9
90kV, 10mA | Similar |
| Panorama
(Xineos-

                   | DAP = 198.8 mGy·cm²

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Image /page/10/Picture/0 description: The image shows the logo for HDX Will. The logo consists of a green and blue square with a white "W" inside, followed by the text "HDX Will" in blue. The text is in a bold, sans-serif font.

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Image /page/11/Picture/0 description: The image shows the logo for HDX Will. The logo consists of a green and blue square with a white "W" inside, followed by the text "HDX Will" in blue. The text is in a bold, sans-serif font.

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Image /page/12/Picture/0 description: The image is a logo for HDX Will. The logo features a green and blue square with a white "W" inside. To the right of the square is the text "HDX Will" in blue, with the "HDX" portion being slightly larger than the "Will" portion. The logo is simple and modern, and the colors are bright and eye-catching.

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

The table also provides rationale for a little difference in support of substantial equivalence to the Predicate devices

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Image /page/14/Picture/0 description: The image shows the logo for HDX Will. The logo features a green and blue square with a white "W" inside. To the right of the square is the text "HDX Will" in blue, with the "HDX" portion being larger than the "Will" portion. The logo is simple and modern, and the colors are bright and eye-catching.

Justification to Support Substantial Equivalence

Image properties

There is a little difference of image properties including MTF and DQE because the used detectors are different. With respect to the functional aspects, the submitted device is enough to perform each modes. The clinical data clearly shows that the DENTRIα series is effective. The little differences of image properties has no effect for diagnosis of the patients in terms of the safety and effectiveness.

Dose Information

The dose information depends on the technological characteristics of device such as FOV size, filtration of X-ray tube, condition of radiation (kV, mA, time) and Source Image Distance (SID). The DENTRIα series has demonstrated that the data does not exceed 50 % according to requirements of Chapter 203.6.4.5 in IEC 60601-2-63. The submitted device is within the same range at similar settings. The dosage does not affect the display outputs.

There are no significant differences between the DENTRIα series and the predicate device.

When compared to the predicate devices (K093590, K142247), the DENTRIα series in this submission presented the substantial equivalence in terms of:

Technological characteristics ●
Output characteristics
Operation Mode .

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

The DENTRIα series has similar intended use and technical characteristics to the predicate device. Based on those information, we conclude that the DENTRIα series is substantially equivalent to the predicate device and does not raise any new questions regarding safety or effectiveness.