FDA Registration
Active
🇰🇷 South Korea
Reverse Drills
Reg #: 3031886796
·
FEI: 3031886796
·
Expires 2025
Products
1
Proprietary Names
44
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- OSSTEM IMPLANT CO., LTD.
- Registration Number
- 3031886796
- FEI Number
- 3031886796
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3, Magokjungang 12-ro
- City
- Gangseo-gu Seoul
- Country
- KR
Owner / Operator
- Firm Name
- Osstem Implant Co., Ltd.
- Operator Number
- 10089729
- Address
- 3, Magokjungang 12-ro
- City
- Gangseo-gu
- State
- Seoul
- Postal Code
- 07789
- Country
- KR
- Correspondent
- Hae Sung Kim
US Agent
- Business Name
- HIOSSEN, Inc.
- Contact Name
- Mateusz Leszczak
- Address
- 85 Ben Fairless Drive
- City
- Fairless Hills
- State
- PA
- ZIP
- 19030
- Country
- US
- [email protected]
- Phone
- 201 2660657
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2024-02-08 |
Proprietary Names
Reverse Drills
Crest Remover
Saw
Shaping Drill
123 Drills
Anchor Drill
Twist Drills
OneMS Drills
Guide Drills
Drill Length Indication
Triple Edge Drills
122 Drills
Cortical Drills
One485 Drills
Three Cutter Drills
Perforation Drill
Flattening Drill
MS Implant Drills
Anchor Screw
Orthodontic Drills
Guided Initial Drill
Saw Protector
Expansion Drills
SET Drills
DIRECT Drills
485 Drills
Tissue Punches
OneGuide Drills
Long Shank Pilot Drill
Digital Lab Analog Reamer Drill
Lance Drills
SideCut Drills
OsstemGuide Drills
CAS Drills
Path Drills
Taper Drills
Bone Profiler
Ultra Drills
Trephine Drills
AutoBone Collector
Initial Drills
LASK Drills
Screw Remover Drills
OneCAS Drills
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility