FDA Registration
Active
🇰🇷 South Korea
CharmFil Flow
Reg #: 3013012934
·
FEI: 3013012934
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DENTKIST, INC.
- Registration Number
- 3013012934
- FEI Number
- 3013012934
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- (Dangjeong-dong) 3, Nongshim-ro
- City
- Gunpo-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K193496
Owner / Operator
- Firm Name
- Dentkist, Inc.
- Operator Number
- 10052020
- Address
- (Dangjeong-dong) 3, Nongshim-ro
- City
- Gunpo-si
- State
- Gyeonggi
- Postal Code
- 15842
- Country
- KR
- Correspondent
- Shin Heang Lee
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2020-12-21 |
Proprietary Names
CharmFil Flow
CharmFil Plus Caps
CharmFil Plus
Establishment Types
Manufacture Medical Device