FDA Registration
Active
🇰🇷 South Korea
TruAbutment DS
Reg #: 3012422333
·
FEI: 3012422333
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TruAbutment Korea Co., Ltd.
- Registration Number
- 3012422333
- FEI Number
- 3012422333
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 104-214~216, 101-1308~1309, 397, Seokcheon-ro
- City
- Bucheon-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K201842
Owner / Operator
- Firm Name
- TRUABUTMENT KOREA CO., LTD.
- Operator Number
- 10052347
- Address
- 104-214~216, 101-1308~1309, 397, Seokcheon-ro,
- City
- Bucheon-si
- State
- Gyeonggi
- Postal Code
- 14449
- Country
- KR
- Correspondent
- Hyuk yong Lee
US Agent
- Business Name
- TruAbutment Inc.
- Contact Name
- Chris Choi
- Address
- 17666 Fitch
- City
- Irvine
- State
- CA
- ZIP
- 92614
- Country
- US
- [email protected]
- Phone
- 714 7675123
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2021-10-26 |
Proprietary Names
TruAbutment DS
Establishment Types
Manufacture Medical Device