FDA Registration
Active
🇰🇷 South Korea
Intermezzo Plus Fixture
Reg #: 3030089802
·
FEI: 3030089802
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MegaGen Implant Co., Ltd. (Research Laboratories)
- Registration Number
- 3030089802
- FEI Number
- 3030089802
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 19, Alphacity 1-ro 31-gil, Suseong-gu
- City
- Daegu
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K053354
Owner / Operator
- Firm Name
- MEGAGEN IMPLANT CO. LTD
- Operator Number
- 9067358
- Address
- 45, Secheon-ro 7-gil, Dasa-eup, Dalseong-gun
- City
- Daegu
- State
- KR-NOTA
- Postal Code
- 42921
- Country
- KR
- Correspondent
- Kwang Bum Park
US Agent
- Business Name
- LK Consulting Group USA, Inc.
- Contact Name
- Priscilla Chung
- Address
- 18881 Von Karman Ave STE 160
- City
- Irvine
- State
- CA
- ZIP
- 92612
- Country
- US
- [email protected]
- Phone
- 714 2025789
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2006-04-13 |
Proprietary Names
Intermezzo Plus Fixture
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility