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
- [email protected]
- Phone
- 714 7675123
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2020-09-01 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2025-04-10 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2016-12-16 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2025-07-07 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2016-12-16 |
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