Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004730368

FEI Number

3004730368

Entity Name

NEOBIOTECH CO., LTD.

City/State/Country

Wonju-si Gangwon, KR

Establishment Address

70, Sinpyeong-ro, Jijeong-myeon, Wonju-si Gangwon 26351, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NEOBIOTECH CO., LTD. (Owner Number: 9066035)

Owner / Operator Contact Address

70, Sinpyeong-ro, Jijeong-myeon, Wonju-si, KR-42 26351, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K190849

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2010-04-29
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2010-04-29
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2012-10-17
DZL	Screw, Fixation, Intraosseous	Dental	Class 2	872.4880	2017-02-27
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2010-04-27
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-07-26
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-05-14
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2024-05-14
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2008-08-25
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2018-10-20
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-10-20
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2012-04-17
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2012-04-17
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2019-08-21
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-08-21

Official Correspondent

No official correspondent registered.

US Agent Details

April Lee Business: Withus Group Inc. Email: withus6664@gmail.com Phone: (909) 2749971

Related Public Records

Same Entity

NEOBIOTECH CO., LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18
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-0007-2018	Implant Direct Sybron Manufacturing, LLC	2	Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004730368. Last updated year: 2026. Please use registration number 3004730368 when referencing this establishment in official correspondence.