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
- [email protected]
- Phone
- 909 2749971
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2010-04-29 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2010-04-29 |
| Screw, Fixation, Intraosseous | DZL | Class 2 | Dental | No | 2017-02-27 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2010-04-27 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2008-08-25 |
| Facebow | KCR | Class 1 | Dental | No | 2025-12-19 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2021-04-01 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2025-12-23 |
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