OSSTEM IMPLANT CO., LTD.

FDA Device Registration & Listing · Gangseo-gu Seoul, KR · Registration 3031886796

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3031886796
FEI Number
3031886796
Entity Name
OSSTEM IMPLANT CO., LTD.
City/State/Country
Gangseo-gu Seoul, KR
Establishment Address
3, Magokjungang 12-ro, Gangseo-gu Seoul 07789, KR
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Osstem Implant Co., Ltd. (Owner Number: 10089729)
Owner / Operator Contact Address
3, Magokjungang 12-ro, Gangseo-gu, KR-11 07789, KR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2024-02-19
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2024-02-19
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-02-19
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2024-02-08
NRU Chair, Dental, Without Operative Unit Dental Class 1 872.6250 2024-02-19
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2024-02-08
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-02-08
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2024-02-08
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-02-08
EID Syringe, Restorative And Impression Material Dental Class 1 872.4565 2024-02-08
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-02-08
NPM Bone Grafting Material, Animal Source Dental Class 2 872.3930 2024-02-19
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-02-08
JEY Plate, Bone Dental Class 2 872.4760 2024-02-08
EIH Powder, Porcelain Dental Class 2 872.6660 2024-02-19
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2024-02-08
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2024-02-08
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-02-08
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 2024-02-08
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-02-08
EIA Unit, Operative Dental Dental Class 1 872.6640 2024-02-19
JEY Plate, Bone Dental Class 2 872.4760 2024-02-08
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2024-02-08
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2024-02-08
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-02-08
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-02-08
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-02-08
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2024-02-08
DZM Needle, Dental Dental Class 1 872.4730 2024-02-08
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-02-08
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-02-08
ELW Material, Impression Dental Class 2 872.3660 2024-02-19
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-02-08
EIF Accessories, Retractor, Dental Dental Class 1 872.4565 2024-02-08
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2024-02-08
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-02-08
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2024-02-08
ECT Driver, Band, Orthodontic Dental Class 1 872.4565 2024-02-08
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-02-08
OAS X-Ray, Tomography, Computed, Dental Radiology Class 2 892.1750 2024-02-19
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2024-02-08
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2024-02-08
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2024-02-08
NYE Fixture Mount Kit Dental Class 1 872.3980 2024-02-19
EHD Unit, X-Ray, Extraoral With Timer Dental Class 2 872.1800 2024-02-19
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2024-02-08
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2024-02-08
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-02-19
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2024-02-19
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-02-26
ELW Material, Impression Dental Class 2 872.3660 2024-02-19
DZA Drill, Dental, Intraoral Dental Class 1 872.4130 2024-02-08
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 2024-02-08
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2024-02-08
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-02-08
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-02-08
EMJ Elevator, Surgical, Dental Dental Class 1 872.4565 2024-02-08
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-02-08
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-02-19
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-02-08
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-02-08
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-02-08
JEY Plate, Bone Dental Class 2 872.4760 2024-02-08
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-02-08
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-02-08
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2024-02-08
ELW Material, Impression Dental Class 2 872.3660 2024-02-19
ELW Material, Impression Dental Class 2 872.3660 2024-02-19
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2024-02-08
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2026-02-05
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2026-02-05

Official Correspondent

Hae Sung Kim

US Agent Details

Mateusz Leszczak Business: HIOSSEN, Inc. Email: peter.l@hiossen.com Phone: (201) 2660657

Related Public Records

Same Entity

Osstem Implant Co., Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3014980469 OSSTEM IMPLANT CO., LTD. Siheung-si Gyeonggi, KR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K081806 Idi Biomedical, LLC IDI IMPLANT SYSTEM 2008-11-07
K120793 Z-Systems AG Z-LOOK3 EVO SLM 2012-12-21
K130140 Intra-Lock International INTRA-LOCK OP DENTAL IMPLANT 2013-08-01
K925778 Nobelpharma USA, Inc. BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES 1993-04-14
K903999 O Co., Inc. OBUTMENT HB 1992-02-11

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0010-2020 Implant Direct Sybron Manufacturing, LLC 2
ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Z-0017-2026 S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil 2
IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N
Z-0018-2020 Implant Direct Sybron Manufacturing, LLC 2
ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0019-2020 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 2
Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
Z-0029-05 Implant Innovations, Inc. 2
EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031886796. Last updated year: 2026. Please use registration number 3031886796 when referencing this establishment in official correspondence.
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