FDA Registration
Active
🇰🇷 South Korea
GCMAB10AS
Reg #: 3004578807
·
FEI: 3004578807
·
Expires 2025
Products
1
Proprietary Names
12
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
- K170384
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 | 2017-08-24 |
Proprietary Names
GCMAB10AS
GCMAB20R
GCMAB30R
GCMAB10AR
GCMAB15ASS
GCMAB15ARS
GCMAB15AS
GCMAB15AR
GCMAB20S
GCMAB10ASS
GCMAB10ARS
GCMAB30S
Establishment Types
Manufacture Medical Device