FDA Registration
Active
🇰🇷 South Korea
OSSTEM IMPLANT CO., LTD.
Reg #: 3003394081
·
FEI: 3003394081
·
Expires 2026
Products
17
Proprietary Names
313
Establishment Types
5
Classifications
17
Registration Details
- Registration Name
- OSSTEM IMPLANT CO., LTD.
- Registration Number
- 3003394081
- FEI Number
- 3003394081
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 66-16, Bansong-ro 513beon-gil,
- City
- Haeundae-gu Busan
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K072896
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
- Martin Shin
- Address
- 85 Ben Fairless Drive
- City
- Fairless Hills
- State
- PA
- ZIP
- 19030
- Country
- US
- [email protected]
- Phone
- 267 7106714
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Scaler, Periodontic | EMN | Class 1 | Dental | No | 2022-11-14 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2008-06-18 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2017-08-22 |
| Implant, Endosseous, Orthodontic | OAT | Class 2 | Dental | No | 2011-04-26 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2012-11-12 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 2019-04-04 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2008-12-12 |
| Curette, Surgical, Dental | EMK | Class 1 | Dental | No | 2022-11-14 |
| Driver, Band, Orthodontic | ECT | Class 1 | Dental | No | 2006-07-18 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2006-07-18 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2006-07-18 |
| Fixture Mount Kit | NYE | Class 1 | Dental | No | 2006-11-01 |
| Screw, Fixation, Intraosseous | DZL | Class 2 | Dental | No | 2019-05-09 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 2022-11-14 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2006-07-18 |
| Oral Surgery Tray | PWL | Class 1 | Dental | No | 2018-07-03 |
| Needle, Dental | DZM | Class 1 | Dental | No | 2019-11-13 |
Proprietary Names
Metal Scaler
GS Fixture System
SS System
US SA Implant System
Orthodontic Screw
TS Abutment System
SMARTbuilder system
MS System (Provisional)
SUFLEX 50ML Impression Gun
OSSTEM Mixing Tip
GS III System
SS SA Fixture System
MS SA Implant System
SET Drills
Bone Profiler
Trephine Drills
Twist Drills
Path Drills
MS Implant Drills
Digital Lab Analog Reamer Drill
LASK Drills
Ultra Drills
Orthodontic Drills
Guided Initial Drill
Drill Length Indication
OneMS Drills
DIRECT Drills
OneGuide Drills
Taper Drills
Guide Drills
Cortical Drills
Triple Edge Drills
123 Drills
AutoBone Collector
Three Cutter Drills
SideCut Drills
CAS Drills
Lance Drills
Tissue Punches
Initial Drills
Crest Remover
Screw Remover Drills
OsstemGuide Drills
Anchor Screw
122 Drills
Expansion Drills
485 Drills
Anchor Drill
OneCAS Drills
Perforation Drill
Long Shank Pilot Drill
Saw
Reverse Drills
Saw Protector
Shaping Drill
One485 Drills
Flattening Drill
Bone Compaction Drill
HG II Fixture System
Sinus Curette
Gracey Curette
Metal Curette
US System
ASMDS
EK Multi Angled 30 Degree Abutment
SB Anchor
NP-Cast Abutment System
TS Fixture System
Link Abutment for CEREC
TS BA Fixture System
HS/HG Prosthetic System
HM SYSTEM
ET/SS Implant System
Osstem Abutment System (TS Multi Angled, US Esthetic-Low, TS Temporary)
AGDSC
SS Abutment System
Prosthetic System
Periosteal Elevator
Mallet
TWMW
Muti Angled Abutment System
OneArch Scan Body Kit
ADVANCED KIT (HAK)
Dr.Cho's Instrument Kit
Smart builder Kit
Osstem Basic Instrument Kit
EFR Full KIT
OneGuide KIT CASE UPPER PLATE
HM KIT (HIOSSEN MS KIT)
OneGuide KIT
ESSET KIT
CUSTOM KIT
Standard KIT lower
Taper Kit Case
EFR KIT
IM-Cure Kit Set
Split Kit - Offset
ESR Full KIT
OneCAS KIT
NEW Prosthetic KIT
Taper Ultra KIT
SmartGuide KIT
122 Taper Full Kit
ESR KIT
Prosthetic Kit Case Low
Parallel Guide Advanced KIT
Lateral Approach Sinus (LAS) KIT
Prosthetic Kit Case Middle
122 Taper KIT
Sinus Lift Kit
Taper KIT
Osteo Kit
Prosthetic Kit Case Upper
Denture 4U Kit
Crestal Approach Sinus (CAS) Kit
122 TAPER KIT CASE MIDDLE PLAT
Split Kit - Straight
ESR FULL KIT COMPONENT
Standard KIT Upper
Positioning Guide FULL Kit
OneMS KIT
Ultra KIT
GBR Kit
Positioning Guide Kit
OssBuilder Kit
Prosthetic Simple KIT (OPSK)
Bone Spreader KIT
123 Straight Full KIT
123 KIT
ORP KIT
Selection KIT
OsstemGuide KIT
Lateral Approach Sinus (LAS) KIT PLUS
Osteotome Kit
485 Kit
One485 KIT
OneGuide Accessory KIT
OnePositioning KIT
OneGuide Training KIT
OneArch KIT
Simple Kit
One Day KIT
HANARO KIT (HSK)
Bone Screw KIT
Ortho KIT
Assist KIT
Sinus KIT
EM Kit
NEW HANARO KIT (HKA)
SURGICAL KIT FOR GS
Bone Compaction KIT
EK Dental Implants and Abutments
Hiossen Prosthetics
OssBuilder Healing Cap
OssBuilder Tenting Screw
Bone Separator
Membrane Seperator
Freer Elevator
Osstem Implant System
Healing Abutment System
SMARTbuilder System(SB1)
GS system
Screw Holders
Removal Bodys
Remover Tools
Bone Condensers
Re-Tap
Machine Screw Drivers
Drill Extensions
Abutment Separate Body
Remover Screws
Bone Carriers
NoMount Drivers
Sleeves
Screw Removal Guides
Protect Caps
Depth Gauges
Polishing Protects
Ti Abutment Laboratory
Screw Removal Tips
Height Gauges
Multi Abutment Outer Driver
OneGuide Reamer (OGRD)
Position Jigs (TS,TS Multi,KS,SS,US Digital Lab Analog)
Torque Connector
Plastic Coping Single
Membrane Lifters
Transfer Impression Copings
Fixture Drivers
Slot Drivers
Pick-up Impression Copings
Digital Lab Analog Screw
Hexed Drivers
Bone Spreaders
Simple Mount Extension
Rigid Outer Driver
Abutment Caps
Driver Handles
Bite Indexs
Multi Abutment Machine Driver
O-ring Abutment Driver
Remover Guides
Templates
Screw Drivers
Torque Wrenches
Scan Body
Plastic Caps
Stopper Sets
Lab Analogs
Impression Copings
Single Guides
CT Checkers (CTCHK)
Torque Extensions
Simple Mount Driver
Narrow Caps
Machine Driver Connector
Guide Pins
Rachet Wrenches
Mount Drivers
Parallel Pins
Bowls
Octa Abutment Driver
Torque Ratch Insert Drivers
Torque Drivers
Drivers
Cover Caps
Outer Drivers
Orthodontic Screw Driver Tip
Defect Gauge
Hand Drivers
Abutment Separate Driver
Abutment Drivers
Burn-out Cylinders
Drill Guides
Denture 4u Guide
Reamer Sets
Machine Drivers
Impression Guns
Taper Fixture Surgical Tap
Angled Torque Driver
Indicator
Solid Abutment Driver
Straight Fixture Surgical Tap
Locator Torque Driver
Posterior Guide
Countersink
Abutment Holder
Torque Driver for Torque Wrench
Path Checker
Scan Body Holding Driver
Plastic Scaler Tip
Hydraulic Membrane Lifter
Bite Impression Coping Drivers
Pin Tools(BP Guide Distance Setup, Single Guide, SmartGuide, Trial)
SmartGuide(Single)
Snap-on Mount
Torque Handle
Smartbrush 2
Open Wrenches
O-Ring Set for Laboratory (OAO100S)
OneGuide Metal Sleeve, Press-in Jig
Guide Screw
OneGuide Anchors(Bone, Fixture, Implant)
Osteotomes(Concave, Expanding)
Simple Mount
Angled Abutment Selector
Universal Handle
TS Scan Healing Abutment Carrier
Bone Mill, Hammer
Orthodontic Screw Removal Tool
Transfer Abutment Separate Tools(Body, Driver)
OneGuide Anchor Pin
OneGuide Drill Handle
Ridge Split Tools(Blade Holder, Chisel)
Protect Screw
Smartbrush 1
Port Multi Tool
KIT Steel Bowl
OsstemGuide Mount
Y-Connector
Multi Angled Abutment Carrier
Tip Tools(Rigid Reamer, Abutment Removal, Bone Tack Holder)
Path Probe
Bone Tack(Ejector, Holder, Handle, Protector)
OsstemGuide Anchor Screw
Impression Cap
Adapter
Mount
Multi Joint Handle
Guides(Bridge, Denture, Positioning)
Driver Separator
Resin Marker
Scan Post
Plastic Scaler Connector
Plastic Cylinder
OneJet SG (OJSG)
Hiossen Simple Instrument KIT
Hiossen Basic Instrument KIT
Osstem Abutment System
Bone Tack
Bone Screw
TS Implant System
OrthAnchor
OSSTEM Implant System
OSSTEM Implant System - Abutment
HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)
Hiossen Prosthetic System
ET Prosthetic System
ET US SS Prosthetic System
US/SS/GS System
Ossbuilder
Dental Needle 27G x 21MM
super orthodontic screw
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device
Complaint File Establishment per 21 CFR 820.198