FDA Registration
Active
🇰🇷 South Korea
Twist Drill (Non-stopper)
Reg #: 3018097239
·
FEI: 3018097239
·
Expires 2025
Products
1
Proprietary Names
23
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- IZENIMPLANT CO., LTD.
- Registration Number
- 3018097239
- FEI Number
- 3018097239
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1, 2Dong, 26-32, Suworam 4-gil, Seotan-myeon
- City
- Pyeongtaek-si Gyeonggi
- Country
- KR
Owner / Operator
- Firm Name
- Izenimplant Co., Ltd.
- Operator Number
- 10080021
- Address
- 1, 2Dong, 26-32, Suworam 4-gil, Seotan-myeon
- City
- Pyeongtaek-si
- State
- Gyeonggi
- Postal Code
- 17703
- 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 |
|---|---|---|---|---|---|
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2021-01-07 |
Proprietary Names
Twist Drill (Non-stopper)
Lindemann Drill
Step Drill
Twist Drill
ZENEX Guide Initial Drill
Dental T-Shaper
Guide Drill
Bone Profiler
ZENEX Guide Flattening Drill
ZENEX Guide Tissue Punch
Taper Drill
Tissue Punch
Cortical Drill
ZENEX Guide Twist Drill
ZENEX Guide Cortical Drill
Taper Cortical Drill
ZENEX Guide Start Drill
Trephine Drill
Point Drill
Guide Drill (Non-stopper)
Drill for Orthodontic
BT Profiler for Healing Abutment
ZENEX Guide Anchor Drill
Establishment Types
Manufacture Medical Device