FDA Registration
Active
🇰🇷 South Korea
SideCut Drill
Reg #: 3011891801
·
FEI: 3011891801
·
Expires 2025
Products
1
Proprietary Names
9
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 |
|---|---|---|---|---|---|
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2021-11-03 |
Proprietary Names
SideCut Drill
Tissue Punch Drill
Final Drill
Lance Drill
Bone Profile Drill
Fixture Tap Drill
Point Drill
Cortical Drill
Initial Drill
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device