FDA Registration Active 🇰🇷 South Korea

TruAbutment Korea Co., Ltd.

Reg #: 3012422333 · FEI: 3012422333 · Expires 2026
Products
5
Proprietary Names
168
Establishment Types
1
Classifications
5

Registration Details

Registration Name
TruAbutment Korea Co., Ltd.
Registration Number
3012422333
FEI Number
3012422333
Status
Active
Expiry Year
2026
Initial Importer
No
Address
104-214~216, 101-1308~1309, 397, Seokcheon-ro
City
Bucheon-si Gyeonggi
Country
KR

Regulatory Submissions

510(k) Number
K183106

Owner / Operator

Firm Name
TRUABUTMENT KOREA CO., LTD.
Operator Number
10052347
Address
104-214~216, 101-1308~1309, 397, Seokcheon-ro,
City
Bucheon-si
State
Gyeonggi
Postal Code
14449
Country
KR
Correspondent
Hyuk yong Lee

US Agent

Business Name
TruAbutment Inc.
Contact Name
Chris Choi
Address
17666 Fitch
City
Irvine
State
CA
ZIP
92614
Country
US
Phone
714 7675123

Products

Device Name Product Code
Abutment, Implant, Dental, Endosseous NHA
Bur, Dental EJL
Drill, Dental, Intraoral DZA
Implant, Endosseous, Root-Form DZE
Accessories, Implant, Dental, Endosseous NDP

Proprietary Names

TruAbutment DS Direct Screw Initial Reamer Direct Screw Reamer Stopper Tru Reamer Kit Base Reamer Direct Screw Final Reamer Cone Reamer TruBase AOT & T-L Abutment Socket Drill TruGUIDE Twist Drill TruGUIDE Kit Point Drill Round Drill Tap Drill Pilot Drill Final Drill Side Cut Drill Reduction Bur Step Drill Initial Drill Bone Profiler Tapered Drill Profile Drill Point Drill Path Drill Flat Drill TruGUIDE Kit Reamer TruGUIDE Kit Twist Drill Straight Drill Surgical Drill Anchor Drill Sinus Drill TruGUIDE Kit Taper Drill URIS Long Implant & Abutments TruAbutment DS, TruBase URIS OMNI Implant URIS Smart Path Implant System & Prosthetic T-Marker Tru 2-way Driver Membrane Elevator Carrier Tru Driver Ratchet Tru Dual Align Scan Body Kit HS Cap Parallel Pin Square Spanner Tissue Punch Multi-Unit Impression Post Pick-Up Type T-L Scan Body T-L Abutment Analog TruLab Analog AOT Delivery Tool Tru Dual Align Scan Body Multi-Unit Abut. Driver Tru Dual Align Direct Screw AOT Digital Analog AOT Plus Scan Body Screw OMNI Angled Gauge Driver Ball Abutment Driver HS Cap Small ioConnect Kit Tru Driver Handpiece TruScan Post Cap Set URIS Scan Body Kit MOD Retractor Handle Torque Wrench TruScan Post Kit AOT Plus Conversion Scan TruScan Post Kit Case URIS All-on-X Pro Kit Membrane Elevator Impression Post Pick-Up Type Impression Post Pick-Up Type Screw URIS Tapered Surgical Kit AOT Straight Driver SP Scan Post Impression Post Transfer Type AOT Plus Scan Body TruDigital Analog Tru Driver Hand TruScan Post AOT Plus Impression Screw Screw Removal Driver Multi-Unit Lab Analog TruGUIDE Guide Sleeve Pushing Jig Multi-Unit Impression Post Transfer Type Scan Body Metal Burn Out Coping Multi-Unit Abutment Analog Multi-Unit Conversion Scan Body Bone Condenser Handle Multi-Unit Scan Body Anchor Pin TruGUIDE Kit TruGUIDE Guide Tissue Punch URIS Prosthetic Driver Kit Impression Post Transfer Type Screw Multi-Unit Impression Post Pick-Up Type Screw AOT Lab Analog Tru ASC Pro Kit Digital Analog Screw Removal Driver Anchor Driver TruScan Body Kit AOT HS Cap Screw AOT Scan Body T-Marker Kit URIS Pylon Crestal Sinus Kit Fixation Pin URIS Scan Post URIS OMNI Surgical Kit Hex Driver Membrane Elevator Tube TruBolt Kit Multi-Unit Digital Analog ASC Driver Unigrip Screw Driver T-Marker Screw TruGUIDE Guide Sleeve URIS Scan Body Mount Connector Depth Gauge Guide Pin URIS Narrow Pylon Kit TruTiming Guide Kit Drill Extension URIS Scan Post Kit Case URIS Surgical Plus Kit Hand Adapter MOD Tip ioConnect Screw Fixture Digital Analog Ball Abutment Analog Pylon Sleeve URIS Pylon Anchor Kit URIS Wide Surgical Kit Multi-Unit Burn Out Cylinder T-L Impression Coping OMNI Mount Driver Fixture Driver ASC Kit URIS SP Surgical Kit Fixture Analog Bone Condenser Titanium Bowl AOT Plus Digital Analog TruDigital Analog Screw SP Scan body URIS Pylon Kit TruBite Scope Tru Dual Align Base Screw URIS Pylon Plus Kit TruBolt Direct Abutment Analog AOT Conversion Scan Body AOT Plus Short Block Out Space TruScan Post Cap T-L Digital Analog Smart Driver Kit TruScan Body TruScan Body Screw MOD Retractor Path Pin T-L Straight Driver Impression Cap ioConnect Fixation Screw URIS Tapered Pylon Kit Extension Adapter

Establishment Types

Manufacture Medical Device