Manufacturer registered with FDA
Hdx Will Corp.
Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, South Korea. Lists 5 dental device types with FDA across 1 registered establishment, and holds 6 510(k) clearances as applicant.
- Device types listed
- 5
- Brands and models
- 10
- 510(k) clearances
- 62016–2021
- Markets registered in
- 838 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 8 markets
Where regulators' registries name Hdx Will Corp. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Hdx Will Corp. | 6 clearances | 2016–2021 | Below |
| Canada | Health Canada | Registration holder | HDX WILL CORP. | 18 | 2019–2019 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | HDX WILL CORP. | 8 | 2017–2023 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | HDX WILL CORP | 3 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | HDX WILL Corp. | 3 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | HDX WILL CORP. | 3 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | HDX WILL CORP. | 2 | 2026–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | HDX WILL Corporation | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Hdx Will Corp. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Computed Tomography X-RayOAS · Class 2 | Dental CBCT | Maker | Dental X-ray systemDENTRI Max (DENTRI?, DENTRI-C?, DENTRI-S?)DENTRI? series (DENTRI?, DENTRI-C?, DENTRI-S?)DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)eco-x Series (eco-x, eco-x-s) | 2016 |
| Extraoral with Timer X-Ray UnitEHD · Class 2 | Dental X-ray units | Maker | Star-X; Intraoral X-ray SystemXcam | 2019 |
| Intraoral X-Ray UnitEAP · Class 2 | Dental X-ray units | Lister | DENTRA III | 2023 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | DENTIOIII series (DENTIOIII, DENTIOIII-S) | 2018 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | Real Arch | 2020 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Hdx Will Corp. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 30 Dec 2021 | K211159 | eco-x Series (eco-x, eco-x-s) | OAS Dental Computed Tomography X-Ray |
| 19 Oct 2021 | K212254 | DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa) | OAS Dental Computed Tomography X-Ray |
| 27 Dec 2019 | K192700 | Xcam | EHD Extraoral with Timer X-Ray Unit |
| 15 Mar 2019 | K190357 | Star-X, Intraoral X-ray System | EHD Extraoral with Timer X-Ray Unit |
| 21 Nov 2018 | K181297 | DENTIOIII series (DENTIOIII, DENTIOIII-S) | MUH Digital Extraoral Source X-Ray System |
| 30 Sep 2016 | K160140 | DENTRIa series | OAS Dental Computed Tomography X-Ray |
Also lists devices cleared under other names
Hdx Will Corp. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Trophy Radiologie (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 19 Apr 1995 | K950532 | TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY | Trophy Radiologie | EAP Intraoral X-Ray Unit |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| HDX WILL CORP.FDA reg. 3013511605 | Heungdeok-gu, Cheongju-si, Chungcheongbuk-do Chungbuk, South Korea | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10053323). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.