FDA Registration
Active
🇰🇷 South Korea
DENU Putty Set(Regular, Fast)
Reg #: 3025307990
·
FEI: 3025307990
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HDI INC.
- Registration Number
- 3025307990
- FEI Number
- 3025307990
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- A-504, 14, Sagimakgol-ro, 45beon-gil, Jungwon-gu
- City
- Seongnam-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K222741
Owner / Operator
- Firm Name
- HDI Inc.
- Operator Number
- 10086700
- Address
- A-1504, 14, Sagimakgol-ro, 45beon-gil, Jungwon-gu
- City
- Seongnam-si
- State
- Gyeonggi
- Postal Code
- 13209
- Country
- KR
- Correspondent
- Taekyou Kim
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Material, Impression | ELW | Class 2 | Dental | No | 2022-12-04 |
Proprietary Names
DENU Putty Set(Regular, Fast)
DENU Heavy Body(Regular, Fast)
DENU Light Body(Regular, Fast)
Establishment Types
Manufacture Medical Device