hdx.co.krEco-x Series (eco-x, Eco-x-s)
HDX WILL Corp.
HDX WILL
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3013508642 | 3013508642 | HDX WILL | 1 | Y | 2026-01-01 | 3435 Wilshire Blvd. Suite 3070 Los Angeles CA US 90010 |
| 3013511605 | 3013511605 | HDX WILL CORP. | 1 | N | 2026-01-01 | #105,106,201,202,203,204, 38, Osongsaengmyeong 4-ro, Osong-eup Heungdeok-gu, Cheongju-si, Chungcheongbuk-do Chungbuk KR 28161 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 08800005200144 | Will3D - The Will3D is one of the components of a PACS (Picture Archiving and Communications System). The Will3D is the software application that provides image viewing and manipulation in the diagnostic imaging setting. | +82215882754 | global@hdx.co.kr |
| 08800005200199 | eco-x series - 'eco-x series (eco-x, eco-x-s)' is 4 in 1 digital equipment that provides CT, Panoramic, Cephalometric, and Model Scan images by using X-Ray scan. It provides 2D images for diagnosing cranial bone tissue including adult and pediatric teeth, jaw, and oral structures and skull. Also, it provides 3D images by reconstructing images acquired by capturing cervical bone and occipital regions.In addition, 'eco-x series' is used as diagnosis for general and/or orthodontic treatment, and also is intended to use for ENT (Ear, Nose, and Throat) and dentomaxillofacial diagnosis. | +82215882754 | global@hdx.co.kr |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 201409 | 1931372236 | K950532 | TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY | EAP | 1995-04-19 |
| 201409 | 2018815780 | K212254 | DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa) | OAS | 2021-10-19 |
| 201409 | 1094696439 | K211159 | eco-x Series (eco-x, eco-x-s) | OAS | 2021-12-30 |
| 201409 | 1762141185 | K211114 | Will3D | LLZ | 2021-12-15 |
| 201409 | 1995957118 | K192700 | Xcam | EHD | 2019-12-27 |
| 201409 | 1042022799 | K190357 | Star-X, Intraoral X-ray System | EHD | 2019-03-15 |
| 201409 | 1417180944 | K181297 | DENTIOIII series (DENTIOIII, DENTIOIII-S) | MUH | 2018-11-21 |
| 201409 | 1958029666 | K172168 | WillCeph | LLZ | 2018-03-21 |
| 201409 | 2029701149 | K170180 | Will3D | LLZ | 2017-05-08 |
| 201409 | 1436222161 | K160140 | DENTRIa series | OAS | 2016-09-30 |
| 201409 | 1823232468 |
Product Codes Associated With Registrations#
PMN#
Will3D
HDX WILL CORP.
DENTRIa Series (DENTRIa, DENTRI-Ca, DENTRI-Sa)
HDX Will Corp.
Xcam
HDX WILL Corp.
Star-X, Intraoral X-ray System
HDX WILL Corp.
DENTIOIII Series (DENTIOIII, DENTIOIII-S)
HDX WILL CORP.
WillCeph
HDX WILL CORP.
Will3D
HDX WILL CORP.
DENTRIa Series
HDX WILL CORP.
GUDID#
Will3D - The Will3D is one of the components of a PACS (Picture Archiving and Communications System). The Will3D is the software application that provides image viewing and manipulation in the diagnostic imaging setting.
2017-12-22
DENTRI Max - The DENTRI Max 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 DENTRI Max 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 DENTRI Max used by physicians, dentists, and x-ray technologists.
2022-04-29
DENTRI Max - The DENTRI Max 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 DENTRI Max 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 DENTRI Max used by physicians, dentists, and x-ray technologists.
2022-04-29
DENTRI Max - The DENTRI Max 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 DENTRI Max 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 DENTRI Max used by physicians, dentists, and x-ray technologists.
2022-04-29
eco-x series - 'eco-x series (eco-x, eco-x-s)' is 4 in 1 digital equipment that provides CT, Panoramic, Cephalometric, and Model Scan images by using X-Ray scan. It provides 2D images for diagnosing cranial bone tissue including adult and pediatric teeth, jaw, and oral structures and skull. Also, it provides 3D images by reconstructing images acquired by capturing cervical bone and occipital regions.In addition, 'eco-x series' is used as diagnosis for general and/or orthodontic treatment, and also is intended to use for ENT (Ear, Nose, and Throat) and dentomaxillofacial diagnosis.
2022-02-21
eco-x series - 'eco-x series (eco-x, eco-x-s)' is 4 in 1 digital equipment that provides CT, Panoramic, Cephalometric, and Model Scan images by using X-Ray scan. It provides 2D images for diagnosing cranial bone tissue including adult and pediatric teeth, jaw, and oral structures and skull. Also, it provides 3D images by reconstructing images acquired by capturing cervical bone and occipital regions.In addition, 'eco-x series' is used as diagnosis for general and/or orthodontic treatment, and also is intended to use for ENT (Ear, Nose, and Throat) and dentomaxillofacial diagnosis.
2022-02-21
DENTRIα series - 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.
2022-02-09
DENTRIα series - 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.
2022-02-09
DENTRIα series - 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.
2022-02-09
DENTRIα Series - Device Description: DENTRIα Series is a dental CT, panoramic X-ray system, which is intended for dental radiographic examination and diagnosis of teeth, jaw and oral structures.
2016-12-25
DENTRIα Series - Device Description: DENTRIα Series is a dental CT, panoramic, cephalometric X-ray system, which is intended for dental radiographic examination and diagnosis of teeth, jaw and oral structures.
2016-12-25
DENTRIα Series - Device Description: DENTRIα Series is a dental CT, panoramic, cephalometric X-ray system, which is intended for dental radiographic examination and diagnosis of teeth, jaw and oral structures.
2016-12-16
DENTIOIII series - The DENTIOIII is intended for dental radiographic examination of the teeth and temporomandibular joints, specifically for panoramic examinations. It is to be used only by dental practitioners and/or radiologists.
2019-03-04
DENTIOIII series - The DENTIOIII-S is intended for dental radiographic examination of the teeth and temporomandibular joints, specifically for panoramic and cephalometric examinations. It is to be used only by dental practitioners and/or radiologists.
2019-03-04
WillCeph - WillCeph is intended for use by orthodontists, oral surgeons, and their clinical staffs in storing and organizing images, including digitla photographs, x-rays, and others. The system includes the capability to trace a cephalometric x-ray, analyze the measurements taken, and make growth or surgical predictions
2018-05-03
Will3D - Will3D is one of the components of a Picture Archiving and Communications System(PACS). Will3D is the software application that provides image viewing and manipulation in the diagnostic imaging setting.
2021-12-21
STAR-X - Star-X is intra-oral X-ray system for dental diagnosis that can radiate X-ray images by irradiating X-rays generated by high voltage to an anode in an X-ray tube and reacting with the receptor (film, sensor).Star-X is a dental X-ray equipment (extra-oral source system) intended for use by qualified dentist or dental technician for both adult and pediatric patient for producing diagnostic dental radiographs for treatment of diseases of the teeth, jaw, and other oral structures using intra-oral image receptors.
2021-04-28
Xcam - This X-ray Unit is intended to be used in portable applications, by a qualified/trained dentist or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of dental structures.
2021-04-28
Real Arch - Real Arch is a dental 3D scanner intended to be used to digitally record topographical characteristics of teeth and surrounding tissues.The Real Arch is composed of a hand-piece, power hub, adapter and usb3.0 cable. The system produces 3D scans for use in computer- assisted design and manufacturing of dental restorations.
2021-01-04