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
Phone
201 2660657

Products

Device Name Product Code
Implant, Endosseous, Root-Form DZE
Abutment, Implant, Dental, Endosseous NHA
Chair, Dental, Without Operative Unit NRU
Accessories, Implant, Dental, Endosseous NDP
Syringe, Restorative And Impression Material EID
Bone Grafting Material, Animal Source NPM
Plate, Bone JEY
Powder, Porcelain EIH
Screw, Fixation, Intraosseous DZL
Unit, Operative Dental EIA
Needle, Dental DZM
Material, Impression ELW
Accessories, Retractor, Dental EIF
Driver, Band, Orthodontic ECT
X-Ray, Tomography, Computed, Dental OAS
Fixture Mount Kit NYE
Unit, X-Ray, Extraoral With Timer EHD
Drill, Dental, Intraoral DZA
Elevator, Surgical, Dental EMJ
Intraoral Camera QJK
Scaler, Periodontic EMN
Chair, Dental, With Operative Unit KLC
Curette, Surgical, Dental EMK
Implant, Endosseous, Orthodontic OAT
Oral Surgery Tray PWL
Bur, Dental EJL

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