DENTRIa series

K160140 · Hdx Will Corp. · OAS · Sep 30, 2016 · Radiology

Device Facts

• Record ID: K160140
• Device Name: DENTRIa series
• Applicant: Hdx Will Corp.
• Product Code: OAS · Radiology
• Decision Date: Sep 30, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Pediatric

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 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.

Device Story

DENTRIα series is a dental/ENT X-ray imaging system (CT, Panoramic, Cephalometric modes). Device uses rotating arm with X-ray generator and flat-panel detector to capture 360-degree rotation sequences of head/neck. Inputs are X-ray attenuation data from patient; software performs reconstruction (FBP algorithm) to produce 3D tomographic images. Operated by physicians, dentists, or X-ray technologists in clinical settings. Output is displayed on workstation for anatomical analysis and diagnosis. Benefits include high-quality diagnostic imaging for dental/orthodontic/ENT treatment planning. Connectivity via Ethernet/RS232 to workstation. Laser used for patient positioning.

Clinical Evidence

Bench testing included electrical safety (AAMI ES60601-1), EMC (IEC 60601-1-2), radiation protection (IEC 60601-1-3), and imaging performance (IEC 61223-3-4). Clinical evidence consisted of patient images reviewed by a licensed professional, concluding good diagnostic quality.

Technological Characteristics

Computed tomography X-ray system; flat-panel detectors (e.g., Teledyne DALSA Xineos-1313); FBP reconstruction; 655nm Class A positioning laser; Ethernet/RS232 connectivity; DICOM 3.0 compatible. Complies with AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-63, and IEC 61223-3-4.

Indications for Use

Indicated for diagnostic imaging of the head and neck, including ENT and dentomaxillofacial areas, for dental and orthodontic treatment planning in adult and pediatric patients. Includes panoramic, cephalometric, and 3D tomographic imaging.

Regulatory Classification

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.

Predicate Devices

• PLANMECA PROMAX 3D MAX (K093590)
• RAYSCANα-Expert 3D (K142247)

Reference Devices

• RAYSCAN α-Expert3D (K122981)
• RAYSCAN α-Expert3D (K121513)
• RAYSCAN α-Expert3D (K131695)
• ENCOMPASS HF100 (K141130)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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<br>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. |

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <span> <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> </span> <span> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> </span> |

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Image /page/3/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, bold font. The logo is simple and modern, and the colors are bright and eye-catching.

# 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,<br>Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do,<br>28161, Korea |
| - Contact Name: | Hyung-suk Oh/ General Manager |
| - Telephone No.: | [phone] |
| - Fax No.: | [phone] |
| - Email Address: | [e-mail] |
| - 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.

1) 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.

- 2) Description of the image detectors used.
# CT detector

-

| | Proposed Device | | Predicate<br>Device #1 | Predicate Device<br>#2 |
|------------------------|-------------------------------|---------------------------|------------------------|------------------------|
| Model | DENTRIα, DENTRI-Cα, DENTRI-Sα | | PROMAX 3D<br>MAX | RAYSCAN α-<br>Expert3D |
| Contents | CT detector (option) | | 3D detector | CT detector |
| Detector model | Xineos-1313 | PaxScan1313DX | Not known | C10900D |
| Manufacturer | Teledyne DALSA | Varian Medical<br>Systems | Not known | Hamamatsu |
| Detector type | Flat panel<br>detector | Flat panel<br>detector | Flat panel<br>detector | Flat panel<br>detector |
| Resolution<br>(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<br>(mm) | 131 x 131 | 130 x 130 | 193 x 242 | 124.8 x 124.8 |
| A/D<br>Conversion | 14 bits | 16 bits | Not known | 13 bits |
| FDA 510(k)<br>Number | Not known | Not known | Not known | K122981<br>(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<br>(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<br>Size) detector |
| Manufacturer | FLAATZ 330N | Not known | PaxScan 4336X |
| Detector type | DR Tech | Not known | Varian |
| Resolution<br>(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<br>(mm) | 38.5% at 0 LP/mm | Not known | 20% at 1 LP/mm |
| A/D<br>Conversion | 193 x 259 | 302 x 249 | 427 x 356 |
| FDA 510(k)<br>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-<br>Expert3D |
| Contents | CEPHALO (SCAN) | Scanning Ceph | Ceph (Scan) detector |
| Detector model | Argus-Ceph (DM-20-<br>08K10) | Not known | XID-C24DS |
| Manufacturer | Teledyne DALSA | Not known | i3System |
| Detector type | Scanning detector<br>(CCD-TDI) | CCD detector | CdTe (Direct type) |
| Resolution<br>(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<br>(mm) | 6.9 x 221 | 6 x 292 | 4.8 x 240 |
| A/D<br>Conversion | 16 bits | Not known | Not known |
| FDA 510(k)<br>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<br>2) Manufacturer: Panoramic Corp.<br>3) 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.

- 3) 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
- 2. Wavelength : 655nm
- 3. Line type : Accurate Straight
- 4. 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.

- 2) 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."

- 3) Biocompatibility
A biocompatibility study is not necessary and proper device disinfection is sufficient to address any health concerns.

- 4) 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<br>(DENTRIα, DENTRI-Cα, DENTRI-Sα) | PLANMECA PROMAX<br>3D MAX | RAYSCANα-Expert 3D | - |
| Manufacturer | HDX WILL CORP. | PLANMECA OY | RAY Co.,Ltd | - |
| Intended Use | The DENTRIα series is<br>a Computed<br>Tomography X-Ray<br>imaging device<br>specialized in<br>diagnosing general<br>dental treatments and<br>orthodontic purpose<br>using Panoramic and<br>Cephalometric images<br>respectively. In | PLANMECA PROMAX<br>3D MAX is a three<br>dimensional Cone<br>Beam Volumetric<br>Tomography (CBVT)<br>x-ray system, which<br>is intended to<br>produce three-<br>dimensional images<br>of the human teeth,<br>jaw and skull. The | RAYSCAN α-Expert<br>3D, panoramic x-ray<br>imaging system with<br>cephalostat, is an<br>extraoral source x-ray<br>system, which is<br>intended for dental<br>radiographic<br>examination of the<br>teeth, jaw, and oral<br>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<br>3) Cephalo | 2) Smart Pan<br>3) Cephalo | 2) Panorama<br>3) Cephalo | |
| | · One shot type | · Planmeca<br>ProCeph | · One shot type | |
| | · Scan type | · Scanning Ceph | · Scan type | |
| X-ray tube assembly | | | | |
| X-ray tube | OPX/105 (C.E.I. X-ray<br>tube) | Toshiba D-067SB | Not known | |
| Focal spot<br>size | 0.5 mm | 0.6 mm | 0.5 mm | Same #2 |
| Target<br>angle | Target angle 5° | Target angle 12° | Target angle 5° | Same #2 |
| Permanent<br>filtration | 0.5 mmAl (IEC 60522) | Inherent Filtration<br>At least 0.8 mm Al at<br>50 kV | Inherent Filtration<br>At least 0.8 mm | Similar |
| Total<br>filtration<br>of X-ray<br>tube<br>assembly | > 2.5 mmAl | 1) 3D: > 2.5 mm Al+<br>0.5 mm Cu<br>2) Smart Pan: > 2.5<br>mm Al<br>3) Cephalo: > 2.5 mm<br>Al | > 2.6 mmAl | Similar |
| | Proposed Device | Predicate Device #1 | Predicate Device #2 | SE note |
| Anode<br>material | Tungsten | Tungsten | Tungsten | Same |
| range of X-<br>ray tube<br>voltage<br>settings | 1) CT:<br>60 - 110 kV± 8 %<br>2) Panorama:<br>60 - 90 kV± 8 %<br>3) Cephalo<br>• One shot type:<br>60 - 110 kV± 8 %<br>• Scan type:<br>60 - 90 kV± 8 % | 1) 3D:<br>60 - 96 kV ± 5 %<br>2) Smart Pan:<br>60 - 84 kV ± 5 %<br>3) Cephalo:<br>60 - 84 kV ± 5 % | 60 - 90kV | Similar |
| range of X-<br>ray tube<br>current<br>settings | 4 - 10mA ± 10 % | 1 - 16 mA ± 10 % | 4 - 17mA | Similar |
| range of<br>irradiation<br>time<br>settings | 1) CT(Normal):<br>8 s or 24 s ± 10 %<br>2) Panorama:<br>14 s and less ± 10 %<br>3) Cephalo<br>• One shot type:<br>0.5, 1, 1.5, 2 s ±<br>10 %<br>• Scan type:<br>8.2 s and less ±<br>10 % | 1) 3D:<br>3.6 - 24 s ± 10 %<br>2) Smart Pan:<br>10 s ± 10 %<br>3) Cephalo:<br>• Planmeca<br>ProCeph:<br>0.1 - 0.8 s ± 10 %<br>• Scanning Ceph:<br>- Normal: 12 -<br>18.7s ± 10 %<br>- High Speed: 6.4 -<br>9.9s ± 10 % | 1) CT: below 14 s<br>2) Panorama:<br>below 14 s<br>3) Cephalo<br>• One shot type:<br>below 2 s<br>• Scan type:<br>below 18 s | Similar |
| Image properties | | | | |
| Detector<br>type | 1) CT: Flat panel<br>2) Panorama: Flat<br>panel<br>3) Cephalo<br>• One shot type: Flat<br>panel<br>• Scan type: CCD | 1) 3D: Flat panel<br>2) Smart Pan: Flat<br>panel<br>3) Cephalo:<br>• Planmeca<br>ProCeph: Flat<br>panel<br>• Scanning Ceph:<br>CCD | 1) CT: Flat panel<br>2) Panorama: Flat<br>panel<br>3) Cephalo<br>• One shot type:<br>Flat panel<br>• Scan type:<br>CdTe (Direct type) | Similar |
| Pixel size | 1) CT:<br>100.1 or 127 µm<br>2) Panorama:<br>100.1 or 127 µm<br>3) Cephalo | 1) 3D:<br>127 µm<br>2) Smart Pan:<br>127 µm<br>3) Cephalo:<br>• Planmeca | 1) CT:<br>200 µm<br>2) Panorama:<br>100 µm<br>3) Cephalo | Similar |
| | Proposed Device | Predicate Device #1 | Predicate Device #2 | SE note |
| | 129 μm<br>• Scan type:<br>27 μm | ProCeph: 139 μm<br>• Scanning Ceph:<br>48 μm | 139 μm<br>• Scan type:<br>100 μm | |
| Active area<br>(mm) | 1) CT:<br>• 131 x 131 mm or<br>• 130 x 130 mm<br>2) Panorama:<br>• 6 x 131 mm or<br>• 3.94 x 128.78 mm<br>3) Cephalo<br>• One shot type:<br>193 x 259 mm<br>• Scan type:<br>6.9 x 221 mm | 1) 3D:<br>193 x 242 mm<br>2) Smart Pan:<br>13 x 162 mm<br>3) Cephalo:<br>• Planmeca<br>ProCeph:<br>302 x 249 mm<br>• Scanning Ceph:<br>6 x 292 mm | 1) CT:<br>124.8 x 124.8 mm<br>2) Panorama:<br>6 x 148 mm<br>3) Cephalo<br>• One shot type:<br>427 x 356 mm<br>• Scan type:<br>4.8 x 240 mm | Similar |
| MTF | 1) CT:<br>• 57% at 1 LP/mm<br>or<br>• 55% at 1 LP/mm<br>2) Panorama:<br>• 57% at 1 LP/mm<br>or<br>• 55% at 1 LP/mm<br>3) Cephalo<br>• One shot type:<br>83.3% at 2 LP/mm<br>• Scan type:<br>70% at 1 LP/mm | Not known | 1) CT:<br>• 60% at 1 LP/mm<br>2) Panorama:<br>• 70% at 1LP/mm<br>3) Cephalo<br>• One shot type:<br>54% at 1LP/mm<br>• Scan type:<br>75% at 1LP/mm | Similar<br>#2 |
| DQE | 1) CT:<br>• 70% at 0 LP/mm<br>or<br>• 58% at 1 LP/mm<br>2) Panorama:<br>• 70% at 0 LP/mm<br>or<br>• 58% at 1 LP/mm<br>3) Cephalo<br>• One shot type:<br>38.5% at 0 LP/mm<br>• Scan type:<br>50% at 0 LP/mm | Not known | 1) CT:<br>• 23% at 1 LP/mm<br>2) Panorama:<br>• 50% at 1LP/mm<br>3) Cephalo<br>• One shot type:<br>20% at 1LP/mm<br>• Scan type:<br>88 % at 1LP/mm | Similar<br>#2 |
| Geometry | | | | |
| | Proposed Device | Predicate Device #1 | Predicate Device #2 | SE note |
| Source<br>Image<br>Distance<br>(SID) | 1) CT: 600 mm<br>2) Panorama: 560 mm<br>3) Cephalo:<br>• One shot type:<br>1790 mm<br>• Scan type:<br>1783 mm | 1) 3D: 600 mm<br>2) Smart Pan:<br>600 mm<br>3) Cephalo: 1700 mm | Not known | Similar<br>#1 |
| Format<br>compatible | DICOM 3.0 Format<br>compatible | DICOM 3.0 Format<br>compatible | DICOM 3.0 Format<br>compatible | Same |
| Dose Information | | | | |
| CT Mode<br>(Xineos-<br>1313 or<br>PaxScan131<br>3DX) | CTDIw = 11.12mGy<br>At the FOV Ø 10 X 8<br>90kV, 10mA | CTDIw = 8.34 mGy<br>At the FOV Ø 10 X 8<br>96kV, 10mA | CTDIw = 10.61 mGy<br>At the FOV Ø 9 X 9<br>90kV, 10mA | Similar |
| Panorama<br>(Xineos-<br>1313) | DAP = 198.8 mGy·cm²<br>At the 80kV, 10mA, 14s | Not known | DAP = 159.0 mGy.cm²<br>At the 80kV, 13mA,<br>14s | Similar<br>#2 |
| Panorama<br>(PaxScan13<br>13DX) | DAP = 119.0 mGy·cm²<br>At the 80kV, 10mA, 14s | Not known | | Similar<br>#2 |
| Cephalo<br>One shot<br>type | DAP = 26.7 mGy·cm²<br>At the 80kV, 10mA,<br>0.5s | Not known | DAP = 38.4 mGy.cm²<br>At the 80kV, 10mA,<br>0.3s | Similar<br>#2 |
| Cephalo<br>Scan type | DAP = 21.3 mGy.cm²<br>At the 80kV, 10mA,<br>8.2 s | Not known | DAP = 65.8 mGy.cm²<br>At the 80kV, 10mA,<br>8.0 s | Similar<br>#2 |

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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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### 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 cha…