OSSTEM IMPLANT CO., LTD.

FDA Device Registration & Listing · Haeundae-gu Busan, KR · Registration 3003394081

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
3003394081
FEI Number
3003394081
Entity Name
OSSTEM IMPLANT CO., LTD.
City/State/Country
Haeundae-gu Busan, KR
Establishment Address
66-16, Bansong-ro 513beon-gil,, Haeundae-gu Busan 48002, KR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
OSSTEM IMPLANT CO LTD (Owner Number: 9062743)
Owner / Operator Contact Address
66-16, Bansong-ro 513beon-gil,, Haeundae-gu, KR-26 48002, KR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered 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 Orthodontic Screw OSSTEM Implant System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EMN Scaler, Periodontic Dental Class 1 872.4565 2022-11-14
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2008-06-18
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2008-06-18
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2017-08-22
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2017-08-22
OAT Implant, Endosseous, Orthodontic Dental Class 2 872.3640 2011-04-26
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-02-26
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2012-11-12
JEY Plate, Bone Dental Class 2 872.4760 2012-11-12
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2008-06-18
EID Syringe, Restorative And Impression Material Dental Class 1 872.4565 2019-04-04
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2010-03-05
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2017-05-18
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2017-05-18
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2012-11-26
DZA Drill, Dental, Intraoral Dental Class 1 872.4130 2008-12-12
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2009-02-16
EMK Curette, Surgical, Dental Dental Class 1 872.4565 2022-11-14
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2008-06-18
ECT Driver, Band, Orthodontic Dental Class 1 872.4565 2006-07-18
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2026-02-05
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2014-09-08
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2013-01-03
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2013-01-03
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2016-11-02
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2017-05-02
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2010-08-23
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2008-09-15
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2012-09-18
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2012-09-18
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-03-24
EJL Bur, Dental Dental Class 1 872.3240 2006-07-18
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-12-13
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2011-10-27
EIF Accessories, Retractor, Dental Dental Class 1 872.4565 2006-07-18
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2015-09-17
NYE Fixture Mount Kit Dental Class 1 872.3980 2006-11-01
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-11-06
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2008-09-15
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 2019-05-09
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2019-05-09
EMJ Elevator, Surgical, Dental Dental Class 1 872.4565 2022-11-14
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-09-26
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2023-09-26
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2026-04-07
JEY Plate, Bone Dental Class 2 872.4760 2013-10-23
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2008-06-18
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2006-07-18
PWL Oral Surgery Tray Dental Class 1 872.4565 2018-07-03
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2019-07-15
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 2019-08-13
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2013-01-15
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2013-01-15
OAT Implant, Endosseous, Orthodontic Dental Class 2 872.3640 2024-01-29
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2016-10-26
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2016-10-26

Official Correspondent

No official correspondent registered.

US Agent Details

Martin Shin Business: HIOSSEN, Inc. Email: regulatoryaffairs@hiossen.com Phone: (267) 7106714

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
3015332784 OSSTEM IMPLANT CO., LTD. SIHEUNG Gyeonggi, KR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K851721 Artiberia 1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS 1985-07-02
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

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 3003394081. Last updated year: 2026. Please use registration number 3003394081 when referencing this establishment in official correspondence.
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