FDA Registration
Active
🇰🇷 South Korea
IHAB4008TH
Reg #: 3004578807
·
FEI: 3004578807
·
Expires 2025
Products
1
Proprietary Names
22
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DENTIUM CO., LTD.
- Registration Number
- 3004578807
- FEI Number
- 3004578807
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 76, Changnyong-daero 256beon-gil, Yeongtong-gu
- City
- Suwon-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K191634
Owner / Operator
- Firm Name
- Dentium USA
- Operator Number
- 9063757
- Address
- 6731
- City
- Cypress
- State
- CA
- Postal Code
- 90630
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2019-11-04 |
Proprietary Names
IHAB4008TH
IHAB5008TH
ISC45BP
IHAB5008TN
IHAB6006TN
IHAB4010TH
IHAB6008TH
IHAB4006TN
IHAB5010TH
IHAB6010TH
IHAB4006TH
IHAB6008TN
IHAB5006TN
IHAB5010TN
IHAB5006TH
IHAB6006TH
ISC55BP
ISC45SP
IHAB4010TN
ISC55SP
IHAB4008TN
IHAB6010TN
Establishment Types
Manufacture Medical Device