FDA Registration
Active
🇰🇷 South Korea
SAVE GBR
Reg #: 3013958319
·
FEI: 3013958319
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DENTIS CO., LTD.
- Registration Number
- 3013958319
- FEI Number
- 3013958319
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6, Yulam-ro, Dong-gu
- City
- Daegu
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K222367
Owner / Operator
- Firm Name
- Dentis Co., Ltd.
- Operator Number
- 10025697
- Address
- 99, Seongseoseo-ro, Dalseo-gu
- City
- Daegu
- State
- KR-27
- Postal Code
- 42718
- Country
- KR
US Agent
- Business Name
- Withus Group Inc.
- Contact Name
- April Lee
- Address
- 106 Superior
- City
- Irvine
- State
- CA
- ZIP
- 92620
- Country
- US
- [email protected]
- Phone
- 909 2749971
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screw, Fixation, Intraosseous | DZL | Class 2 | Dental | No | 2023-03-27 |
Proprietary Names
SAVE GBR
Establishment Types
Manufacture Medical Device