FDA Registration
Active
🇰🇷 South Korea
DENTRA III
Reg #: 3013511605
·
FEI: 3013511605
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HDX WILL CORP.
- Registration Number
- 3013511605
- FEI Number
- 3013511605
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- #105,106,201,202,203,204, 38, Osongsaengmyeong 4-ro, Osong-eup
- City
- Heungdeok-gu, Cheongju-si, Chungcheongbuk-do
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K950532
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
US Agent
- Business Name
- IRC USA
- Contact Name
- Charles Mack
- Address
- 2950 E Lindrick Dr
- City
- Chandler
- State
- AZ
- ZIP
- 85249
- Country
- US
- [email protected]
- Phone
- 931 6254938
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Unit, X-Ray, Intraoral | EAP | Class 2 | Dental | No | 2023-05-30 |
Proprietary Names
DENTRA III
Establishment Types
Export Device to the United States But Perform No Other Operation on Device