FDA Registration
Active
🇰🇷 South Korea
SHINHUNG CO. LTD.
Reg #: 9710613
·
FEI: 3000199218
·
Expires 2026
Products
6
Proprietary Names
17
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- SHINHUNG CO. LTD.
- Registration Number
- 9710613
- FEI Number
- 3000199218
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 42-25, 27beon-gil,, Dongsan-ro, Danwon-gu
- City
- Ansan-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K213749
Owner / Operator
- Firm Name
- SHINHUNG CO. LTD.
- Operator Number
- 9046958
- Address
- Shinhung Bldg, 450, Chongpa-ro, Jung-gu,
- City
- SEOUL
- State
- KR-NOTA
- Postal Code
- 04510
- Country
- KR
US Agent
- Business Name
- Mtech Group LLC
- Contact Name
- Dave Kim
- Address
- 7505 Fannin St Ste 610
- City
- Houston
- State
- TX
- ZIP
- 77054
- Country
- US
- [email protected]
- Phone
- 713 4672607
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Crown, Preformed | ELZ | Class 1 | Dental | No | 2009-04-02 |
| Clamp, Rubber Dam | EEF | Class 1 | Dental | No | 2012-09-25 |
| Needle, Dental | DZM | Class 1 | Dental | No | 2003-12-31 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2023-12-15 |
| Unit, Operative Dental | EIA | Class 1 | Dental | No | 2023-05-11 |
| Chair, Dental, Without Operative Unit | NRU | Class 1 | Dental | No | 2023-05-19 |
Proprietary Names
ALU CROWN
PERMA GOLDEN CROWN
KIDS CROWN
PERMA CROWN
Primary Molar S.S. Crown
KIDS ZIRCONIA CROWN
Stainless Steel Primary Molar Crown
KIDS GOLDEN CROWN, KIDS RING CROWN, KIDS ZIRCONIA CROWN TRY-IN
K-CLAMP
SHINJECT
K-irrigator tips
KF94 3D Mask
Shinhung Dental Mask
KF94 2D Mask
G7, Dental Operative Unit and Accessories
TAURUS C1
Chair-C1, Chair-G7
Establishment Types
Manufacture Medical Device