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
Phone
267 7106714

Products

Device Name Product Code
Scaler, Periodontic EMN
Implant, Endosseous, Root-Form DZE
Abutment, Implant, Dental, Endosseous NHA
Implant, Endosseous, Orthodontic OAT
Plate, Bone JEY
Syringe, Restorative And Impression Material EID
Drill, Dental, Intraoral DZA
Curette, Surgical, Dental EMK
Driver, Band, Orthodontic ECT
Bur, Dental EJL
Accessories, Retractor, Dental EIF
Fixture Mount Kit NYE
Screw, Fixation, Intraosseous DZL
Elevator, Surgical, Dental EMJ
Accessories, Implant, Dental, Endosseous NDP
Oral Surgery Tray PWL
Needle, Dental DZM

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