FDA Registration
Active
🇰🇷 South Korea
OSSTEM IMPLANT CO., LTD.
Reg #: 3031886796
·
FEI: 3031886796
·
Expires 2026
Products
26
Proprietary Names
351
Establishment Types
1
Classifications
26
Registration Details
- Registration Name
- OSSTEM IMPLANT CO., LTD.
- Registration Number
- 3031886796
- FEI Number
- 3031886796
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3, Magokjungang 12-ro
- City
- Gangseo-gu Seoul
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K123471
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 |
|---|---|---|---|---|---|
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2024-02-19 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2024-02-19 |
| Chair, Dental, Without Operative Unit | NRU | Class 1 | Dental | No | 2024-02-19 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2024-02-08 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 2024-02-08 |
| Bone Grafting Material, Animal Source | NPM | Class 2 | Dental | No | 2024-02-19 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2024-02-08 |
| Powder, Porcelain | EIH | Class 2 | Dental | No | 2024-02-19 |
| Screw, Fixation, Intraosseous | DZL | Class 2 | Dental | No | 2024-02-08 |
| Unit, Operative Dental | EIA | Class 1 | Dental | No | 2024-02-19 |
| Needle, Dental | DZM | Class 1 | Dental | No | 2024-02-08 |
| Material, Impression | ELW | Class 2 | Dental | No | 2024-02-19 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2024-02-08 |
| Driver, Band, Orthodontic | ECT | Class 1 | Dental | No | 2024-02-08 |
| X-Ray, Tomography, Computed, Dental | OAS | Class 2 | Radiology | No | 2024-02-19 |
| Fixture Mount Kit | NYE | Class 1 | Dental | No | 2024-02-19 |
| Unit, X-Ray, Extraoral With Timer | EHD | Class 2 | Dental | No | 2024-02-19 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2024-02-08 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 2024-02-08 |
| Intraoral Camera | QJK | Class 2 | Dental | No | 2024-02-19 |
| Scaler, Periodontic | EMN | Class 1 | Dental | No | 2024-02-08 |
| Chair, Dental, With Operative Unit | KLC | Class 1 | Dental | No | 2024-11-19 |
| Curette, Surgical, Dental | EMK | Class 1 | Dental | No | 2024-02-08 |
| Implant, Endosseous, Orthodontic | OAT | Class 2 | Dental | No | 2024-02-08 |
| Oral Surgery Tray | PWL | Class 1 | Dental | No | 2024-02-19 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2024-02-08 |
Proprietary Names
ETII SA Fixture System
HIOSSEN implant System
TS Fixture System
K3 - Chair only
Torque Driver for Torque Wrench
Solid Abutment Driver
Plastic Scaler Tip
Simple Mount Extension
Outer Drivers
Plastic Scaler Connector
Port Multi Tool
Screw Removal Guides
Bone Mill, Hammer
OsstemGuide Anchor Screw
Scan Body
Defect Gauge
Bone Condensers
Torque Handle
Locator Torque Driver
Denture 4u Guide
Octa Abutment Driver
Templates
Orthodontic Screw Removal Tool
OneGuide Metal Sleeve, Press-in Jig
Angled Abutment Selector
OneJet SG (OJSG)
Torque Drivers
OneGuide Reamer (OGRD)
Rachet Wrenches
Path Checker
Machine Drivers
Single Guides
Y-Connector
Orthodontic Screw Driver Tip
NoMount Drivers
Hexed Drivers
Scan Post
Multi Abutment Machine Driver
Ti Abutment Laboratory
Parallel Pins
Ridge Split Tools(Blade Holder, Chisel)
Drivers
Remover Tools
Machine Screw Drivers
Path Probe
Posterior Guide
Height Gauges
Stopper Sets
Narrow Caps
OneGuide Drill Handle
KIT Steel Bowl
TS Scan Healing Abutment Carrier
Remover Screws
Impression Cap
Reamer Sets
Angled Torque Driver
OsstemGuide Mount
Drill Guides
Hand Drivers
Digital Lab Analog Screw
Resin Marker
Countersink
Pick-up Impression Copings
Tip Tools(Rigid Reamer, Abutment Removal, Bone Tack Holder)
Torque Ratch Insert Drivers
Bone Tack(Ejector, Holder, Handle, Protector)
Protect Screw
Torque Wrenches
Simple Mount Driver
Torque Connector
Universal Handle
Abutment Holder
Sleeves
Taper Fixture Surgical Tap
Re-Tap
Guide Screw
Bone Spreaders
Plastic Caps
Mount
Hydraulic Membrane Lifter
Multi Abutment Outer Driver
Remover Guides
Transfer Impression Copings
Screw Removal Tips
Snap-on Mount
Plastic Cylinder
Simple Mount
Rigid Outer Driver
Protect Caps
Multi Joint Handle
Indicator
OneGuide Anchors(Bone, Fixture, Implant)
Abutment Caps
Driver Separator
Pin Tools(BP Guide Distance Setup, Single Guide, SmartGuide, Trial)
Screw Holders
Fixture Drivers
Guide Pins
Driver Handles
Plastic Coping Single
Straight Fixture Surgical Tap
Abutment Separate Body
Guides(Bridge, Denture, Positioning)
Bowls
Screw Drivers
Machine Driver Connector
CT Checkers (CTCHK)
Depth Gauges
Bone Carriers
Torque Extensions
Drill Extensions
Cover Caps
Multi Angled Abutment Carrier
Burn-out Cylinders
Scan Body Holding Driver
O-Ring Set for Laboratory (OAO100S)
Bite Indexs
Open Wrenches
SmartGuide(Single)
Removal Bodys
Abutment Separate Driver
Bite Impression Coping Drivers
Slot Drivers
Polishing Protects
Osteotomes(Concave, Expanding)
Membrane Lifters
Impression Copings
Position Jigs (TS,TS Multi,KS,SS,US Digital Lab Analog)
Mount Drivers
O-ring Abutment Driver
Smartbrush 2
Transfer Abutment Separate Tools(Body, Driver)
Impression Guns
Adapter
Lab Analogs
Smartbrush 1
OSSTEM Implant System
ET Ziocera Angled Abutments
Prosthetic System
ET Gold Cast Abutments
SUFLEX 50ML Impression Gun
OSSTEM Mixing Tip
Link Abutment for CEREC
A-Graft
Ossbuilder
Estar-Z
GS system
US SA Implant System
OssBuilder Tenting Screw
OssBuilder Healing Cap
K3 V1.2
SMARTbuilder System(SB1)
TS BA Fixture System
SS SA Fixture System
ET Prosthetic System
ET Multi Abutments
ET Freeform ST Abutments
ET Ziocera Abutments
OSSTEM Implant System - Abutment
ET Quick Temporary Abutments
ET Rigid Abutments
GS Fixture System
Dental Needle 27G x 21MM
Hiossen Prosthetics
Ziocera & Convertible System
HYSIL Impression Material
NP-Cast Abutment System
Mallet
TWMW
Periosteal Elevator
SS System
TS Implant System
ASMDS
Osstem Abutment System (TS Multi Angled, US Esthetic-Low, TS Temporary)
T2-C. T2-CS
US System
HM SYSTEM
GS III System
122 Taper Full Kit
OneGuide Accessory KIT
EFR KIT
Smart builder Kit
Selection KIT
Bone Screw KIT
Osstem Basic Instrument Kit
Positioning Guide FULL Kit
Bone Spreader KIT
Simple Kit
Dr.Cho's Instrument Kit
ORP KIT
Split Kit - Straight
Prosthetic Simple KIT (OPSK)
ESSET KIT
485 Kit
OneGuide KIT CASE UPPER PLATE
123 Straight Full KIT
OneMS KIT
122 TAPER KIT CASE MIDDLE PLAT
Parallel Guide Advanced KIT
Taper Kit Case
CUSTOM KIT
Lateral Approach Sinus (LAS) KIT PLUS
NEW HANARO KIT (HKA)
Lateral Approach Sinus (LAS) KIT
Ortho KIT
Crestal Approach Sinus (CAS) Kit
OneGuide KIT
ESR KIT
Standard KIT Upper
ADVANCED KIT (HAK)
Positioning Guide Kit
EFR Full KIT
OnePositioning KIT
ESR FULL KIT COMPONENT
IM-Cure Kit Set
Osteo Kit
Prosthetic Kit Case Low
Standard KIT lower
OneGuide Training KIT
ESR Full KIT
HANARO KIT (HSK)
123 KIT
OneArch KIT
Prosthetic Kit Case Upper
122 Taper KIT
SmartGuide KIT
One485 KIT
Osteotome Kit
GBR Kit
OssBuilder Kit
Denture 4U Kit
Ultra KIT
Split Kit - Offset
OneCAS KIT
Sinus KIT
HM KIT (HIOSSEN MS KIT)
EM Kit
Prosthetic Kit Case Middle
Taper Ultra KIT
NEW Prosthetic KIT
Taper KIT
One Day KIT
Sinus Lift Kit
Assist KIT
SURGICAL KIT FOR GS
N1
MS System (Provisional)
US/SS/GS System
ET Hybrid Abutment
EM Provisional
TS Abutment System
HYSIL Impression Materials (Heavy, Mono and Bite)
One485 Drills
Three Cutter Drills
OneGuide Drills
Drill Length Indication
DIRECT Drills
Orthodontic Drills
Guided Initial Drill
122 Drills
Cortical Drills
Lance Drills
SideCut Drills
SET Drills
Twist Drills
485 Drills
Tissue Punches
AutoBone Collector
Initial Drills
Anchor Drill
Taper Drills
Long Shank Pilot Drill
OsstemGuide Drills
CAS Drills
OneMS Drills
Expansion Drills
Anchor Screw
Saw Protector
Shaping Drill
Crest Remover
Digital Lab Analog Reamer Drill
LASK Drills
Reverse Drills
MS Implant Drills
Screw Remover Drills
OneCAS Drills
Guide Drills
Path Drills
Triple Edge Drills
Flattening Drill
Bone Profiler
Ultra Drills
Trephine Drills
Perforation Drill
Saw
123 Drills
Bone Tack
Bone Screw
ET/SS Implant System
SB Anchor
Freer Elevator
Bone Separator
Membrane Seperator
ET NP-Cast Abutments
ET Esthetic Low Gold Cylinder
Hiossen Prosthetic System
ET Abutment System
Multi Angled Abutment System
HS/HG Prosthetic System
SMARTbuilder system
ET US SS Prosthetic System
Osstem Implant System
HYSIL Plus Impression Materials
HYSIL Super Fast Impression Material
HG II Short Fixture System
EK Multi Angled 30 Degree Abutment
SNAP Wired, SNAP Wireless
AVANA DENTAL IMPLANT SYSTEM
Multi Angled Abutment
ET SMARTFit Abutment
Metal Scaler
ETIII Nano-HA Fixture System
EM SA Implant System
Super Orthodontic Screw
MS SA Implant System
T2 Plus (T2-C-P, T2-CS-P)
K5
T1 C, T1-CS
Metal Curette
Gracey Curette
Sinus Curette
Orthodontic Screw
ET Temporary Abutments
ET Multi-NP Cast Cylinder
ET Combination Angled Cylinder
ET Transfer Abutments
ET Stud Abutments
ET Angled Abutments
ET Esthetic Low Temporary Cylinder
ET Convertible Angled Cylinder
Osstem Abutment System
ET Multi-Angled Abutments
ETIII SA Fixture System (D3.2)
Hiossen Simple Instrument KIT
Hiossen Basic Instrument KIT
SS Abutment System
ET IV SA Dental Implants
Estar-ZE
HG II Fixture System
EK Dental Implants and Abutments
AGDSC
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility