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
Phone
909 2749971

Products

Device Name Product Code
Drill, Dental, Intraoral DZA
Abutment, Implant, Dental, Endosseous NHA
Implant, Endosseous, Root-Form DZE
Elevator, Surgical, Dental EMJ
Handle, Instrument, Dental EJB
Excavator, Dental, Operative EKC
Accessories, Implant, Dental, Endosseous NDP

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