FDA Registration
Active
🇰🇷 South Korea
Machine Driver Connector
Reg #: 3031886796
·
FEI: 3031886796
·
Expires 2025
Products
1
Proprietary Names
132
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 |
|---|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2024-02-08 |
Proprietary Names
Machine Driver Connector
Adapter
Depth Gauges
Transfer Abutment Separate Tools(Body, Driver)
Impression Guns
Smartbrush 1
Transfer Impression Copings
Stopper Sets
OneGuide Drill Handle
TS Scan Healing Abutment Carrier
Bite Impression Coping Drivers
Simple Mount Extension
Polishing Protects
Outer Drivers
Pick-up Impression Copings
Torque Ratch Insert Drivers
Bone Tack(Ejector, Holder, Handle, Protector)
Bone Mill, Hammer
Resin Marker
Orthodontic Screw Removal Tool
OneGuide Metal Sleeve, Press-in Jig
Angled Abutment Selector
Scan Post
OneGuide Reamer (OGRD)
Screw Drivers
Countersink
Lab Analogs
Solid Abutment Driver
Plastic Scaler Tip
Defect Gauge
Indicator
Open Wrenches
OneGuide Anchors(Bone, Fixture, Implant)
SmartGuide(Single)
Abutment Caps
Driver Separator
Mount
Plastic Cylinder
Parallel Pins
Ridge Split Tools(Blade Holder, Chisel)
Protect Caps
Drivers
Multi Joint Handle
Bone Carriers
Narrow Caps
Torque Extensions
KIT Steel Bowl
Hydraulic Membrane Lifter
Multi Abutment Outer Driver
Templates
Straight Fixture Surgical Tap
Rigid Outer Driver
Torque Wrenches
Simple Mount Driver
OsstemGuide Anchor Screw
Taper Fixture Surgical Tap
Tip Tools(Rigid Reamer, Abutment Removal, Bone Tack Holder)
Re-Tap
Guide Screw
Protect Screw
Bone Spreaders
Plastic Caps
Torque Driver for Torque Wrench
Ti Abutment Laboratory
Torque Connector
Universal Handle
OneJet SG (OJSG)
Scan Body Holding Driver
O-Ring Set for Laboratory (OAO100S)
Sleeves
Digital Lab Analog Screw
Osteotomes(Concave, Expanding)
Locator Torque Driver
Impression Cap
Pin Tools(BP Guide Distance Setup, Single Guide, SmartGuide, Trial)
Screw Holders
Guide Pins
Machine Drivers
Driver Handles
Plastic Coping Single
Orthodontic Screw Driver Tip
Impression Copings
Position Jigs (TS,TS Multi,KS,SS,US Digital Lab Analog)
NoMount Drivers
Hexed Drivers
O-ring Abutment Driver
Multi Abutment Machine Driver
Bone Condensers
Torque Handle
CT Checkers (CTCHK)
Denture 4u Guide
Octa Abutment Driver
Removal Bodys
Abutment Separate Body
Abutment Separate Driver
Slot Drivers
Guides(Bridge, Denture, Positioning)
Drill Extensions
Cover Caps
Multi Angled Abutment Carrier
Angled Torque Driver
OsstemGuide Mount
Drill Guides
Hand Drivers
Remover Screws
Rachet Wrenches
Path Checker
Single Guides
Reamer Sets
Y-Connector
Abutment Holder
Scan Body
Smartbrush 2
Remover Tools
Simple Mount
Machine Screw Drivers
Path Probe
Posterior Guide
Height Gauges
Burn-out Cylinders
Torque Drivers
Bite Indexs
Bowls
Plastic Scaler Connector
Membrane Lifters
Port Multi Tool
Screw Removal Guides
Mount Drivers
Remover Guides
Fixture Drivers
Screw Removal Tips
Snap-on Mount
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility