FDA Registration Active 🇰🇷 South Korea

NEOBIOTECH CO., LTD.

Reg #: 3004730368 · FEI: 3004730368 · Expires 2026
Products
8
Proprietary Names
313
Establishment Types
1
Classifications
8

Registration Details

Registration Name
NEOBIOTECH CO., LTD.
Registration Number
3004730368
FEI Number
3004730368
Status
Active
Expiry Year
2026
Initial Importer
No
Address
70, Sinpyeong-ro, Jijeong-myeon
City
Wonju-si Gangwon
Country
KR

Regulatory Submissions

510(k) Number
K090377

Owner / Operator

Firm Name
NEOBIOTECH CO., LTD.
Operator Number
9066035
Address
70, Sinpyeong-ro, Jijeong-myeon
City
Wonju-si
State
Gangwon
Postal Code
26351
Country
KR

US Agent

Business Name
Withus Group Inc.
Contact Name
April Lee
Address
106 Superior
City
Irvine
State
CA
ZIP
92620
Country
US
Phone
909 2749971

Products

Device Name Product Code
Abutment, Implant, Dental, Endosseous NHA
Implant, Endosseous, Root-Form DZE
Screw, Fixation, Intraosseous DZL
Accessories, Implant, Dental, Endosseous NDP
Drill, Dental, Intraoral DZA
Facebow KCR
Guide, Surgical, Instrument FZX
Tray, Impression, Preformed EHY

Proprietary Names

CMI implant EB System CMI Implant IS II active Neo GBR System Surgical Guide Lateral Anchor Sleeve Digital Lab Analog Digital Lab Analog Set Scan Post Scan Bar Maxy Connector BT Scan Body Set Neo PickCap Impression KIT Prosthesis KIT Prosthetic Planning KIT Universal Prosthetic KIT Conical Guide Surgical Guide IS Vertical Anchor(In Fixture) - Screw Direction Pin Bone Condenser Ball Lab Analog Bone Carrier NeoGuide Vertical Anchor(In Bone) Oral Scan Body PickCap Impression Set Lab Analog Surgical Guide Tissue Punch Pick Cap Impression Screw Drill Stop O-ring SET EB Fixture Driver Dual Hex Driver Abutment Screw Abutment Positioner Driver EZ-Cover Cap Driver NeoGuide S-Mini Fixture Driver IS Encoded Healing Abutment Pin NeoGuide Vertical Anchor(In Bone) - Screw S-Wide Drill Stopper NeoGuide Tissue Punch Unigrip Driver Surgical Guide Ratchet Connector MD Parallel Pin Plastic Impression Coping Cap NeoGuide Screw Stopper NeoGuide Handle Guide Rescue Hex Driver IT Transfer Impression Coping Abutment Driver NeoGuide Bone Condenser and Aqua Connector Body Multi Unit Abutment Driver Fixture Remover IS Fixture Driver EZ-Screw Fixation Drill Stopper Drill Stop O-ring PickCap Impression Pincette Driver Handle Surgical Guide Handle Guide Two Way Hex Driver IT Fixture Driver Pick Cap Impression Body Torque Ratchet Wrench Tissue Punch NeoGuide IS Lab Cylinder Set Shank Driver NeoGuide IT Fixture Driver Ball Abutment Driver NeoGuide IS Lab Cylinder MD Spacer CTi Contouring Plier S-Mini Fixture Driver Aqua Hose Set Driver Holder & Depth Gauge Parallel Pin Oral Scan Body Set NeoGuide Aqua Hose Set Multi Unit System Angled Driver Multi Unit Abutment Lab Analog Depth Gauge Bone Chisel Aqua Tap Multi Unit Abutment Gold Lab Cylinder Bone Inserter Surgical Guide Adapter Removal Tool 3D Former NeoGuide Aqua Connector Ball Type Driver Torque Wrench EZ-Phillips Head Driver Surgical Guide IS Fixture Adapter Screw Surgical Guide IS Vertical Anchor(In Fixture) NeoGuide Sinus Stopper Scan Body Screw S-Mini Parallel Pin NeoGuide Drill Stopper Multi Gauge Multi Unit Abutment Scan Body Surgical Guide Vertical Anchor(In Bone) S-Mini Lab Analog Friction Driver Surgical Guide Contra Angle Connector MD Spacer Set Torx Driver Internal Direction Pin Short Drill Stopper NeoGuide Vertical Anchor(In Fixture) - Screw Fixture Remover KIT ACM Stopper Driver Holder Fixture Remover Screw Thread Former PG Hand Driver CTi-mem Cover Cap Driver Surgical Guide Lateral Anchor Pin NeoGuide Bone Condenser and Aqua Connector IS Impression Coping Set Plastic UCLA Surgical Guide Vertical Anchor(In Bone) -Screw Slot Driver Lab Cylinder Set PickCap Impression Cap Lab Cylinder NeoGuide Lateral Anchor Pin Multi Unit Abutment Holder Prosthetic Planning SCA Stopper SCS Driver Bone Spreader Quick Tight Screw Remover NeoGuide Ratchet Connector Guide Holder NeoGuide IS Lab Cylinder Pin Drill Stopper SR Driver Holder FR Screw Hex Driver Lateral Stopper Perfect Guide EZ-Break Driver Crestal Stopper Scan Body External Direction Pin IS OS Lab Analog Multi Unit Abutment Plastic Lab Cylinder Plastic Coping Impression Coping IS Direction Pin NeoGuide Drill Offset Stopper Surgical Guide Drill Stopper EB Transfer Impression Coping Set Ratchet NeoGuide Wide Conversion Sleeve Internal Guide Surgical Guide IS Fixture Adapter Contra Angle Connector Rotary Elevator NeoGuide Sinus Depth Gauge Multi Unit Abutment Scan Body Screw Internal Submerged Direction Pin NeoGuide IS Fixture Driver Drill Handle Surgical Guide Lab Analog External Guide Sinus Elevator Abutment Positioner Screw Fixation Drill Stopper Phillips Head Screw Driver EZ-Ti-Mem Push Driver Dia. Indicator Guide Abutment Positioner Set Hex Driver Ratchet Connector Safe Disk Protective Cover NeoGuide Vertical Anchor(In Fixture) Drill Extension Surgical Guide IS Fixture Driver Aqua System EZ-Handle Connector Mini implant Impression Cap YK Torque Driver YK Lab Cylinder YK PickCap Impression Body YK Lab Cylinder Body YK Lab Cylinder Screw YK Lab Analog Power Octa IS Scan Body NeoGuide Surgical Guide IT Lab Analog FR Driver Abutment Remover Grip IT Scan Body Set YK Cylinder Holder Fixture Remover Wrench YK PickCap Impression Screw Digital Lab Analog Screw IT Scan Body Remover Screw Scan Bar Screw SmileArch ScanBody KIT Power Hex Reverse Scan Body Power Positioner YK PickCap Impression Set Abutment Remover Screw Remover Guide Holder ALX-BT Lab Analog ALX-BT Fixture Driver IS Scan Body Set IS Multi Unit Abutment System Protective Cap IS-III active short Implant ALX Taper Drill Sinus Crestal Approach KIT Sinus Lateral Approach KIT VAROGuide Sinus KIT VAROGuide KIT Neo Master KIT EZ-GBR KIT Neo Core KIT VAROGuide Mini KIT Round Bur S-Mini KIT Accessory KIT S-Wide Multi Profile NeoGuide Single Drill S-Mini Guide Drill Profile Tap NeoGuide Twist Drill S-Mini Surgical Tap VAROGuide Accessory KIT Reverse Drill Side Cutter Claw NeoGuide Sinus S-Reamer AutoChip Maker C-Guide Reamer Neo NaviGuide KIT Screw Remover KIT2 Bone Expander S-Wide KIT Surgical Guide Lateral Anchor Drill Point Drill NeoGuide Sinus Twist Drill Surgical Guide Drill Twist Stop Drill C-Reamer Screw Fixation Drill IS Full KIT NeoGuide Cortical Tap Safe Disk NeoGuide Initial Drill Neo Surgical KIT Stop Drill KIT LS-Reamer NeoGuide Lateral Anchor Pin Drill SinusAll Drill EZ-Screw Fixation Drill NeoGuide Sinus C-Reamer Surgical Tap Drill Cortical Tap LS Round Bur Multi Profile NeoGuide Bone Trimmer AutoChip Maker Set IS Cortical Drill Neo NaviGuide KIT - Narrow Type S-Wide Tap Drill S-Reamer Guide Drill NeoGuide Full Tap Surgical Guide Bone Planer Trephine Drill S-Wide Twist Surgical Drill Surgical Guide IS Fixture Profile Tap SCA Initial Drill NeoGuide Cortical Drill Neo Sinusall KIT S-Narrow KIT NeoGuide Point Drill EB Bone Profiler IS Bone Profiler Cortical Drill Surgical Tap SinusAll Initial Drill NeoGuide Taper Drill Ridge Wider KIT Lindemann Drill S-Mini Twist Surgical Drill EB&IT KIT NeoGuide Immediate Placement Drill Dia Marker Twist Surgical Drill Bone Trimmer Bone Planer All-in-One Remover KIT Reverse Center Drill Neo MAXY KIT EZ-Stop Drill EZ-Stop Drill KIT Neo Signature KIT IT Margin Profile MAXY-Hard MAXY-Soft IS-III active System CMI IMPLANT IS SYSTEM IS-III active System_S-narrow Type IS-III HActive Fixture CMI implant IT System SAM Gothic Arch SmileArch M KIT Surgical Guide Sleeve S-Mini Implant System IT-III active System SAM Bite Plate SAM Partially Smile Line Plate

Establishment Types

Manufacture Medical Device