FDA Registration
Active
🇰🇷 South Korea
Crest Remover
Reg #: 3003394081
·
FEI: 3003394081
·
Expires 2025
Products
1
Proprietary Names
45
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- OSSTEM IMPLANT CO., LTD.
- Registration Number
- 3003394081
- FEI Number
- 3003394081
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 66-16, Bansong-ro 513beon-gil,
- City
- Haeundae-gu Busan
- Country
- KR
Owner / Operator
- Firm Name
- OSSTEM IMPLANT CO LTD
- Operator Number
- 9062743
- Address
- 66-16, Bansong-ro 513beon-gil,
- City
- Haeundae-gu
- State
- Busan
- Postal Code
- 48002
- Country
- KR
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 | 2008-12-12 |
Proprietary Names
Crest Remover
Screw Remover Drills
CAS Drills
Lance Drills
485 Drills
122 Drills
Ultra Drills
Three Cutter Drills
Triple Edge Drills
LASK Drills
OneGuide Drills
Anchor Screw
DIRECT Drills
Guided Initial Drill
OneMS Drills
MS Implant Drills
AutoBone Collector
Guide Drills
Drill Length Indication
Cortical Drills
123 Drills
Tissue Punches
Initial Drills
Twist Drills
SideCut Drills
Bone Profiler
Path Drills
SET Drills
OsstemGuide Drills
Taper Drills
Trephine Drills
Orthodontic Drills
Expansion Drills
Digital Lab Analog Reamer Drill
Anchor Drill
Reverse Drills
One485 Drills
Long Shank Pilot Drill
Perforation Drill
Saw
OneCAS Drills
Shaping Drill
Flattening Drill
Saw Protector
Bone Compaction Drill
Establishment Types
Manufacture Medical Device