FDA Registration
Active
🇰🇷 South Korea
Lab analog
Reg #: 3011891801
·
FEI: 3011891801
·
Expires 2025
Products
1
Proprietary Names
51
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- POINTIMPLANT Co., Ltd
- Registration Number
- 3011891801
- FEI Number
- 3011891801
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- B1 and 3F, 7, Hyoyeol-ro, Buk-gu
- City
- Busan
- Country
- KR
Owner / Operator
- Firm Name
- PointImplant Co Ltd
- Operator Number
- 10083213
- Address
- B1 and 3F, 7, Hyoyeol-ro, Buk-gu
- City
- Busan
- State
- KR-26
- Postal Code
- 46509
- Country
- KR
- Correspondent
- Joarak Chung
US Agent
- Business Name
- Mtech Group LLC
- Contact Name
- Dave Kim
- Address
- 7505 Fannin St. Suite 610
- City
- Houston
- State
- TX
- ZIP
- 77054
- Country
- US
- [email protected]
- Phone
- 713 4672607
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2021-11-08 |
Proprietary Names
Lab analog
Impression Coping Driver
OTS-KIT
Drill Extension
PRO-KIT
Excellent Solid Analog
Multi Impression Coping
Pincette
Vertical Anchor
Stopper
Bite Impression Coping Cap
Multi Abutment Driver
Fixture Mount Screw
Ratchet Wrench
Fixture Driver
Hand Driver
Mount Driver
Ball Analog
OTA-KIT
Pick-Up Impression Coping
Scan Body Screw
BITE-KIT
Slot Driver
Guide pin
Machine Screw Driver
Fixture pin
Torque Wrench
Fixture analog
Bite Scan Body
Mount Open Wrench
Depth Gage
Scan Body
Fixture Mount
Multi Guide Pin
Torque Extension
Mount Extension
Abutment Removal Tip
Remove Driver
Transfer Impression coping
NAVI-KIT
Ball Abutment Driver
Plastic Sleeve
Bite Impression Coping
Digital Lab Analog
Solid Driver
Multi Abutment Carrier
Parallel Pin
OT-KIT
Torque Driver
Drill Tube
No-Mount Driver
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198