Who is the manufacturer of DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)?

Hdx Will Corp. filed the 510(k) submission for DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa) (K212254).

What is the FDA product code for DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)?

OAS. It is classified under 21 CFR 892.1750 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)?

DENTRIα series (DENTRIα, DENTRI-Cα, DENTRI-Sα) (K160140).

Who can help prepare an FDA 510(k) submission like DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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

K212254 · Hdx Will Corp. · OAS · Oct 19, 2021 · Radiology

Device Facts

Record ID	K212254
Device Name	DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)
Applicant	Hdx Will Corp.
Product Code	OAS · Radiology
Decision Date	Oct 19, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1750
Device Class	Class 2
Attributes	Pediatric

Intended 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.

Device Story

The DENTRIa series is a dental X-ray imaging system used by physicians, dentists, and technologists in clinical settings. It captures 360-degree rotation sequences of head and neck areas, including ENT and dentomaxillofacial regions. The system uses an X-ray generator and detector that rotate around the patient; X-rays are attenuated by dense structures (bones) and pass through less dense tissues. The device transforms these X-ray projections into 3D tomographic images via computer-processed reconstruction. Output is displayed for anatomical analysis to support dental and orthodontic diagnosis and treatment planning. The device benefits patients by providing detailed 3D anatomical visualization for clinical decision-making.

Clinical Evidence

Bench testing only. Performance assessed via electrical safety (ES60601-1), EMC (IEC 60601-1-2), radiation protection (IEC 60601-1-3), and dental X-ray equipment standards (IEC 60601-2-63). Imaging performance validated per IEC 61223-3-4. Detector performance (MTF, DQE) compared to predicate devices per FDA guidance for Solid State X-ray Imaging Devices, demonstrating equal or better diagnostic image quality.

Technological Characteristics

Computed tomography X-ray system; X-ray tube (OPX/105); detectors (CMOS or a-Si/a-Se TFT); 14-bit A/D conversion; 0.5 mm focal spot (IEC 60336); 0.5 mmAl inherent filtration; >2.5 mmAl total filtration. Connectivity: DICOM 3.0 compatible. Software: Filtered Back Projection (FBP) reconstruction. Standards: ES60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-63, 21 CFR 1020.30/31.

Indications for Use

Indicated for diagnostic imaging in adult and pediatric dentistry, orthodontics, and otolaryngology, specifically for head, neck, ENT, and dentomaxillofacial areas using panoramic, cephalometric, and 3D tomographic X-ray 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

DENTRIα series (DENTRIα, DENTRI-Cα, DENTRI-Sα) (K160140)

Reference Devices

DENTIOIII, DENTIOIII-S (K181297)
RCT800 (K192737)

Related Devices

K160140 — DENTRIa series · Hdx Will Corp. · Sep 30, 2016
K200469 — PAPAYA 3D Premium & PAPAYA 3D Premium Plus · Genoray Co., Ltd. · Sep 16, 2020
K090467 — DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D · VATECH Co., Ltd. · Jan 8, 2010
K150354 — PAPAYA 3D Plus · Genoray Co., Ltd. · Dec 10, 2015
K083917 — X-RAY, TOMOGRAPHY, COMPUTED, DENTAL · Suni Medical Imaging, Inc. · Jun 2, 2009

Submission Summary (Full Text)

{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) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary [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 2) Manufacturer: HDX WILL Corp. 3) 510(k) number: K160140 | 1) System name: DENTRIα, DENTRI-Ca, DENTRI-Sα 2) Manufacturer: HDX WILL Corp. 3) 510(k) number: K160140 | Xineos-2301: 1) System name: DENTIOIII, DENTIOIII-S 2) Manufacturer: HDX WILL Corp. 3) 510(k) number: K181297 Xineos-2301S: Not known | | | TFT: a-Si (Thin- Film Transistor, Amorphous Silicon) | | | | | 1) System name: RCT800 2) Manufacturer: Ray Co., Ltd. 3) 510(k) number: K192737 | | | {6}------------------------------------------------ ## 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 2. Panorama 3. Cephalo 1) One-Shot type 2) Scan type 4. Model Scan | 1. CT 2. Panorama 3. Cephalo 1) One-Shot type 2) 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) 1. CT 60-110 kV ±8% 2. Panorama 60-90 kV ±8% 3. Cephalo 1) One-Shot type 60-110 kV ±8% 2) Scan type 60-90 kV ±8% | WDG90 (Optional) 1. CT 60-90 kV ±8% 2. Panorama 60-90 kV ±8% 3. Cephalo 1) One-Shot type 60-90 kV ±8% 2) Scan type 60-90 kV ±8% | 1. CT 60-110 kV ±8% 2. Panorama 60-90 kV ±8% 3. Cephalo 1) One-Shot type 60-110 kV ±8% 2) 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) 2. Panorama 1.2-14.0 s ± (5 % + 50 ms) 3. Cephalo 1) One-Shot type 0.5 s to 2.0 s ± (5 % + 50 ms) (in 0.5 s increments) 2) Scan type 2.5-8.0 s ± (5 % + 50 ms) 4. Model Scan 24 s | 1. CT(Normal) 8 s or 24 s ± 10 % 2. Panorama 14 s and less ± 10 % 3. Cephalo 1) One shot type 0.5, 1, 1.5, 2 s ± 10 % 2) Scan type 8.2 s and less ± 10 % | | Similar | | Image Properties | | | | | | Detector type | 1. CT CMOS or TFT:a-Si 2. Panorama CMOS or TFT:a-Si 3. Cephalo 1) One-shot type TFT:a-Se 2) Scan type CMOS | 1. CT Flat panel 2. Panorama Flat panel 3. Cephalo 1) One shot type Flat panel 2) Scan type CCD | | Similar | | Pixel size | 1. CT 100.1 um or 119 um 2. Panorama 100.1 um or 119 um 3. Cephalo 1) One-shot type 129.0 um 2) Scan type 99.0 um | 1. CT: 100.1 or 127 μm 2. Panorama: 100.1 or 127 μm 3. Cephalo 1) One shot type: 129 μm 2) Scan type: 27 μm | | Similar | | Active area (mm) | 1. CT 131 x 131 or 149.464 x 149.464 2. Panorama 6 x 130 or | 1. CT: 131 x 131 mm or 130 x 130 mm 2. 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…