FDA Registration
Active
🇰🇷 South Korea
PNUADD Standard Surgical KIT_Parallel Pin, Fixture Driver, Hex Driver, Drill Stopper;
Reg #: 3029973772
·
FEI: 3029973772
·
Expires 2025
Products
1
Proprietary Names
10
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PNUAdd Co., Ltd.
- Registration Number
- 3029973772
- FEI Number
- 3029973772
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 145, Geumdan-ro, Geumjeong-gu, 2F
- City
- Busan
- Country
- KR
Owner / Operator
- Firm Name
- PNUAdd Co., Ltd.
- Operator Number
- 10089089
- Address
- 145, Geumdan-ro, Geumjeong-gu, 2F
- City
- Busan
- State
- KR-26
- Postal Code
- 46241
- Country
- KR
- Correspondent
- Jong-ho Lee
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2025-06-11 |
Proprietary Names
PNUADD Standard Surgical KIT_Parallel Pin, Fixture Driver, Hex Driver, Drill Stopper;
PNUADD Taper Surgical KIT_ Taper Cortical Drill, Parallel Pin, Hand Driver, Ratchet Driver, No Mount Driver;
PNUADD TGK KIT_Lateral Anchor Driver, One Direction Torque Wrench
PNUADD TGK KIT_Lateral Anchor Drill, Guide Fixture Driver, Mount Driver, Hand Driver;
PNUADD Standard Surgical KIT_Depth Gaouge, Torque Wrench
PNUADD Standard Surgical KIT_Lance Drill, Stright Stopper Drill, Final Stopper Drill;
PNUADD TGK KIT_Drill Guide, Vertical Anchor Screw, Lateral Anchor Screw, Guide Point Drill;
PNUADD TGK KIT_Guide Initial Drill, Guide Step Drill, Guide Taper Drill, Guide Tissue Punch;
PNUADD Taper Surgical KIT_ Lance Drill, Lindemann Drill, Drill Extension, Straight Drill, Taper Surgical Drill;
PNUADD Taper Surgical KIT_ Fixture Driver, Depth Gauge, Torque Ratchet;
Establishment Types
Manufacture Medical Device