FDA Registration
Active
🇰🇷 South Korea
SURE DENT CORPORATION
Reg #: 9616142
·
FEI: 3001421500
·
Expires 2026
Products
6
Proprietary Names
10
Establishment Types
3
Classifications
6
Registration Details
- Registration Name
- SURE DENT CORPORATION
- Registration Number
- 9616142
- FEI Number
- 3001421500
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- #809, 52, SAGIMAKGOL-RO, JUNGWON-GU
- City
- SEONGNAM-SI Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K132526
Owner / Operator
- Firm Name
- SURE DENT CORPORATION
- Operator Number
- 9034040
- Address
- #809, 52, SAGIMAKGOL-RO, JUNGWON-GU,
- City
- SEONGNAM-SI
- State
- Gyeonggi
- Postal Code
- 13210
- Country
- KR
- Correspondent
- HOJIN - BAE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gutta-Percha | EKM | Class 1 | Dental | No | 1998-06-03 |
| Point, Paper, Endodontic | EKN | Class 1 | Dental | No | 1998-06-03 |
| Preparer, Root Canal Endodontic | EKQ | Class 1 | Dental | No | 2024-06-04 |
| Cord, Retraction | MVL | Class U | Unknown | No | 2014-01-14 |
| Resin, Root Canal Filling | KIF | Class 2 | Dental | No | 2024-06-04 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2009-11-04 |
Proprietary Names
GUTTA-PERCHA POINTS
ABSORBENT PAPER POINT
Sure-Prep
Knit-Pak+ Cord (Premier Dental Products Co.)
Sure-Cord Plus
Sure-Paste
RETRACTION CORD
Sure-Cord Clean
Sure-Cord
Sure-Seal Root
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)