FDA Registration
Active
🇰🇷 South Korea
HDX WILL CORP.
Reg #: 3013511605
·
FEI: 3013511605
·
Expires 2026
Products
6
Proprietary Names
12
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- HDX WILL CORP.
- Registration Number
- 3013511605
- FEI Number
- 3013511605
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- #105,106,201,202,203,204, 38, Osongsaengmyeong 4-ro, Osong-eup
- City
- Heungdeok-gu, Cheongju-si, Chungcheongbuk-do Chungbuk
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K212254
Owner / Operator
- Firm Name
- HDX WILL CORP.
- Operator Number
- 10053323
- Address
- #105,106,201,202,203,204, 38, Osongsaengmyeong 4-ro, Osong-eup
- City
- Heungdeok-gu, Cheongju-si, Chungcheongbuk-do
- State
- KR-NOTA
- Postal Code
- 28161
- Country
- KR
- Correspondent
- Chris Lee
US Agent
- Business Name
- HDX WILL
- Contact Name
- Won Jung
- Address
- 3435 Wilshire Blvd., Suite 3070
- City
- Los Angeles
- State
- CA
- ZIP
- 90010
- Country
- US
- [email protected]
- Phone
- 213 9994596
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| X-Ray, Tomography, Computed, Dental | OAS | Class 2 | Radiology | No | 2021-11-29 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2021-12-16 |
| Unit, X-Ray, Extraoral With Timer | EHD | Class 2 | Dental | No | 2020-01-08 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2020-12-30 |
| System, X-Ray, Extraoral Source, Digital | MUH | Class 2 | Dental | No | 2018-12-04 |
| Unit, X-Ray, Intraoral | EAP | Class 2 | Dental | No | 2023-05-30 |
Proprietary Names
DENTRI Max (DENTRI?, DENTRI-C?, DENTRI-S?)
DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)
Will3D
Xcam
WillCeph
Real Arch
Star-X; Intraoral X-ray System
Dental X-ray system
DENTRI? series (DENTRI?, DENTRI-C?, DENTRI-S?)
DENTIOIII series (DENTIOIII, DENTIOIII-S)
eco-x Series (eco-x, eco-x-s)
DENTRA III
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device