FDA Registration
Active
🇰🇷 South Korea
Outer Drivers
Reg #: 3029914934
·
FEI: 3029914934
·
Expires 2025
Products
1
Proprietary Names
134
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- OSSTEM IMPLANT CO LTD
- Registration Number
- 3029914934
- FEI Number
- 3029914934
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 13, Neunggil-ro 115beon-gil, Danwon-gu
- City
- Ansan Gyeonggi
- 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
- 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 |
|---|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2006-07-18 |
Proprietary Names
Outer Drivers
Simple Mount Driver
Driver Handles
Templates
Screw Drivers
Torque Extensions
Narrow Caps
Torque Drivers
Torque Wrenches
Fixture Drivers
Slot Drivers
Impression Guns
Cover Caps
Height Gauges
Depth Gauges
Screw Removal Tips
Burn-out Cylinders
Membrane Lifters
Protect Caps
Bowls
Bone Spreaders
Mount Drivers
Simple Mount Extension
Ti Abutment Laboratory
Machine Screw Drivers
Position Jigs (TS,TS Multi,KS,SS,US Digital Lab Analog)
Single Guides
Plastic Caps
Straight Fixture Surgical Tap
OneGuide Reamer (OGRD)
Abutment Holder
Path Checker
Posterior Guide
Countersink
CT Checkers (CTCHK)
Locator Torque Driver
Torque Connector
Scan Body
Drivers
Sleeves
Hexed Drivers
Lab Analogs
Impression Copings
Abutment Separate Driver
Abutment Drivers
Transfer Impression Copings
Remover Screws
Parallel Pins
Stopper Sets
Rachet Wrenches
Abutment Separate Body
Bone Condensers
Re-Tap
Reamer Sets
Machine Drivers
Guide Pins
Drill Extensions
Torque Ratch Insert Drivers
Screw Removal Guides
Drill Guides
Taper Fixture Surgical Tap
Bite Indexs
Pick-up Impression Copings
Plastic Coping Single
Remover Tools
Polishing Protects
Screw Holders
Removal Bodys
Abutment Caps
Multi Abutment Outer Driver
Hand Drivers
Bone Carriers
Remover Guides
O-ring Abutment Driver
Angled Torque Driver
NoMount Drivers
Indicator
Denture 4u Guide
Machine Driver Connector
Torque Driver for Torque Wrench
Orthodontic Screw Driver Tip
Digital Lab Analog Screw
Solid Abutment Driver
Defect Gauge
Rigid Outer Driver
Multi Abutment Machine Driver
Octa Abutment Driver
Plastic Scaler Tip
Bone Mill, Hammer
Orthodontic Screw Removal Tool
Bite Impression Coping Drivers
Multi Angled Abutment Carrier
Bone Tack(Ejector, Holder, Handle, Protector)
OsstemGuide Anchor Screw
Hydraulic Membrane Lifter
Universal Handle
Torque Handle
Resin Marker
Scan Body Holding Driver
Y-Connector
Angled Abutment Selector
Adapter
OsstemGuide Mount
Transfer Abutment Separate Tools(Body, Driver)
OneGuide Drill Handle
OneGuide Metal Sleeve, Press-in Jig
Path Probe
Simple Mount
Scan Post
Ridge Split Tools(Blade Holder, Chisel)
SmartGuide(Single)
TS Scan Healing Abutment Carrier
Tip Tools(Rigid Reamer, Abutment Removal, Bone Tack Holder)
OneGuide Anchors(Bone, Fixture, Implant)
Port Multi Tool
OneJet SG (OJSG)
Multi Joint Handle
Smartbrush 1
Protect Screw
OneGuide Anchor Pin
Guides(Bridge, Denture, Positioning)
Osteotomes(Concave, Expanding)
Guide Screw
Impression Cap
Smartbrush 2
Mount
Plastic Cylinder
Pin Tools(BP Guide Distance Setup, Single Guide, SmartGuide, Trial)
Driver Separator
Open Wrenches
Snap-on Mount
KIT Steel Bowl
O-Ring Set for Laboratory (OAO100S)
Plastic Scaler Connector
Establishment Types
Manufacture Medical Device