FDA Registration
Active
🇰🇷 South Korea
INNOBIOSURG CO., LTD.
Reg #: 3008309654
·
FEI: 3008309654
·
Expires 2026
Products
7
Proprietary Names
183
Establishment Types
1
Classifications
7
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Registration Details
- Registration Name
- INNOBIOSURG CO., LTD.
- Registration Number
- 3008309654
- FEI Number
- 3008309654
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 44-19, Techno Street 10, YUSUNG-GU,
- City
- Daejeon
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K201621
Owner / Operator
- Firm Name
- InnoBioSurg Co.,Ltd
- Operator Number
- 10032324
- Address
- 44-19, Techno Street 10,, Yuseong-gu,
- City
- Daejeon
- State
- KR-30
- Postal Code
- 305500
- Country
- KR
- Correspondent
- Je Won Wang
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 |
|---|---|---|---|---|---|
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2011-06-05 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2020-07-15 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2020-06-17 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 2010-05-03 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2015-09-08 |
| Excavator, Dental, Operative | EKC | Class 1 | Dental | No | 2015-09-08 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2015-08-24 |
Proprietary Names
Magic Marking Drill
Magic Half Drill
Magic Tap Drill
Tissue Punch
AMII GPS Depth Drill
Magic Guide Pin
Drill Stopper
Magic Drill
Magic Tap Pin
Surgical Guide Anchor Drill
AMII GPS Magic Drill
Magic Sinus Drill
Surgical Guide Final Drill
Drill Extension
Surgical Guide Initial Drill
Magic Guide Pin SET
AMII GPS Final Drill
1.6 Lindemann Drill
Drill Stopper Holder
AMII GPS Second Drill
AMII GPS Ratchet Tap Drill
AMII GPS Initial Drill
Magic Short Drill
AMII GPS Machined Tap Drill
Magic Tap Body
Magicore Anchor Drill
AMII GPS Drill
Surgical Guide Tap Drill
Magic Multiunit Abutment Carrier
GPS Drill
Guide Drill
Magic Multiunit Abutment Impression coping Guide Pin (Pick-up type)
Magic Multiunit Abutment Impression coping Guide Pin (Transfer type)
Trephine Bur
Magic Depth Drill
Magic Tap Guide
Magicore GPS Break Drill
Surgical Guide Depth Drill
Sinus Drill
Semilunar Tissue Punch
Periosteum Lifter
AMII Implant System
innobiosurg
Magic UCLA Abutment System
AMII Implant Closing Screw
Magic Multiunit Digital Cap
Torque Wrench
Open Wrench
AMII Implant Healing Cap
AMII Implant Healing Cap Screw
CCM Abutment System
Spoon Excavator
IBS Spoon Excavator
Premilled Titanium Block System
AMII GPS Drill Tube
Magic Tapper
Magic Standard KIT
AMII GPS Digital KIT
Magicore GPS Guide Pin
Magic Guide Kit
Magicore Scan Body Screw
Solid Abutment Lab Analog
Magic Drill KIT
Removal KIT
Screw Abutment Impression (Transfer type)
Magicore Impression Coping (Transfer type, One piece type)
Magic Sinus & Expansion KIT
Ratchet Driver
Multiunit Abutment Impression Coping (Pick-up type)
Surgical Guide Bone Pusher
Periodontal Probe
Drill Sleeve
Housing Stabilizer
AMII Narrow KIT
Magicore GPS Sleeve Drill
Magic Drill Kit
Magicore Scan Body
Magic Narrow KIT
Magic Motion Housing Inner Protector
Magicore Ratchet Driver
Guide Screw for Magicore (Pick-up type)
Magic Diagnosis KIT
Sub/screw Abutment Analog
Impression Coping Guide Screw (Transfer type)
Magicore Path Probe
Tap Guide
Magic Holder SET
Guide Housing Positioner Driver
Magic FC Solid Abutment Impression Cap
AMII GPS Metal Sleeve
Angled Hand Lever
Multiunit Impression Coping Guide Screw (Transfer type)
Magic FC Surgical Guide Kit
AMII Implant Guide Screw (Pick-up type)
AMII GPS Machined Fixture Driver
Guide Housing Positioner Kit
Magicore KIT
Parallel pin
Magic Holder
Magic Expander
Magic Motion Driver
Plastic Coping
Surgical Guide Template
1.2 Hexa Driver
Multiunit Abutment Impression Coping (Transfer type)
AMII Implant Impression coping (Transfer type)
Magic Kit
Magic Prosthetics KIT
Sub hex Impression Coping (Pick-up type)
Surgical Guide Ratchet Driver
AMII GPS Close Sleeve
AMII Implant Lab Analog
AMII Implant Scan Body Screw
Magic Sinus Kit
Magic Split
Magicore Solid Abutment Lab Analog
Magic Guide KIT
Magicore Machined Driver
Screw Abutment Driver
Multiunit Abutment Lab Analog
Magic Sinus & Expansion Kit
Magicore Surgical Guide Kit
Angulator Carrier
Magicore Impression Coping Guide Pin (Transfer type)
Impression Coping and Analog
Magic Multiunit Abutment Impression coping (Pick-up type)
Magic FC Lab Analog
Machine 1.2 Hex Driver
Magicore GPS Anchor Screw Machined Driver
AMII AMERICA KIT
Magicore Lab Analog
Transfer Impression Cap
Magicore GPS Anchor Screw
Sub Non-hex Impression Coping (Pick-up type)
Anchor Screw
Positioner Angulator
Magic Multiunit Abutment Impression coping (Transfer type)
AMII GPS KIT
Guide Screw for Magicore (Transfer type)
Magic Motion KIT
AMII Implant Digital Lab Analog
Impression Coping Guide Screw (Pick-up type)
Surgical Guide Sinus Lifter
Magic Ruler
AMII Implant Scan Body
Bone Pusher
Magic Motion Kit
AMII GPS Ratchet Fixture Driver
Sub hex Impression Coping (Transfer type)
Surgical Guide Machine Driver
AMII KIT
Screw Abutment Impression (Pick-up type)
Magicore Impression coping (Transfer type)
Sub Non-hex Impression Coping (Transfer type)
Magicore Impression coping (Pick-up type)
Magic Multiunit Abutment Lab Analog
AMII Implant Multiunit Digital Lab Analog
Magic Multiunit Digital Lab Analog
Magic Sinus Lifter
Multiunit Impression Coping Guide Screw (Pick-up type)
AMII Implant Impression coping (Pick-up type)
AMII Implant Machined Driver
AMII Implant Ratchet Driver
Bone Remover Body
Surgical Guide Magic Expander
Solid Abutment Drvier
Bone Remover Hook Tip
Resin Protector
Magic FC Machined Driver
Magicore Solid Abutment Impression Cap
AMII Implant Impression coping Guide Pin (Transfer type)
Magic FC Scan Body
Expansion Kit
Magic Lifter
Magic FC Ratchet Driver
Bone Remover
Positioner Base
Magic Sinus KIT
AMII GPS Ratchet Driver
Path Pin
Magicore Digital Lab Analog
Bone Remover Drill Tip
Surgical Guide Magic Split
Establishment Types
Manufacture Medical Device