Truabutment Korea Co L T D

FDA Filings

This page includes the latest FDA filings for Truabutment Korea Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3012422333
• FEI Number: 3012422333
• Name: TruAbutment Korea Co., Ltd.
• Owner & Operator: TRUABUTMENT KOREA CO., LTD.
• Contact Address: 397 Seokcheon-ro #101-202, Ojeong-gu ; Bucheon-si KR-41 Gyeonggido 14449 KR
• Official Correspondent:
  • Kiyoon Nam
  • 82-32-6784688-x
• US Agent:
  • Chris Choi
  • TruAbutment Inc.
  • 714 9561488
  • chris.choi@truabutment.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 397 Seokcheon-ro #101-202, Ojeong-gu ; Bucheon-si Gyeonggido, 14449 KR
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 08800076464551 Truabutment Korea Co.,Ltd	TruDriver Handpiece	2025-10-02
GUDID 08800076464544 Truabutment Korea Co.,Ltd	TruDriver Handpiece	2025-10-02
GUDID 08800076464537 Truabutment Korea Co.,Ltd	TruDriver Handpiece	2025-10-02
GUDID 08800076464520 Truabutment Korea Co.,Ltd	TruDriver Handpiece	2025-10-02
GUDID 08800076464513 Truabutment Korea Co.,Ltd	TruDriver Handpiece	2025-10-02
GUDID 08800076464506 Truabutment Korea Co.,Ltd	TruDriver Handpiece	2025-10-02
GUDID 08800076464490 Truabutment Korea Co.,Ltd	TruDriver Handpiece	2025-10-02
GUDID 08800076464483 Truabutment Korea Co.,Ltd	TruDriver Handpiece	2025-10-02
GUDID 08800076464476 Truabutment Korea Co.,Ltd	TruDriver Handpiece	2025-10-02
GUDID 08800076464469 Truabutment Korea Co.,Ltd	TruDriver Handpiece	2025-10-02
GUDID 08800076464452 Truabutment Korea Co.,Ltd	TruDriver Handpiece	2025-10-02
GUDID 08800076464445 Truabutment Korea Co.,Ltd	TruDriver Handpiece	2025-10-02
GUDID 08800076464438 Truabutment Korea Co.,Ltd	TruDriver Handpiece	2025-10-02
GUDID 08800076464421 Truabutment Korea Co.,Ltd	TruDriver Handpiece	2025-10-02
GUDID 08800076462892 Truabutment Korea Co.,Ltd	TRU RATCHET DRIVER	2025-10-02
GUDID 08800076462885 Truabutment Korea Co.,Ltd	TRU RATCHET DRIVER	2025-10-02
GUDID 08800076462878 Truabutment Korea Co.,Ltd	TRU RATCHET DRIVER	2025-10-02
GUDID 08800076462861 Truabutment Korea Co.,Ltd	TRU RATCHET DRIVER	2025-10-02
GUDID 08800076462854 Truabutment Korea Co.,Ltd	TRU RATCHET DRIVER	2025-10-02
GUDID 08800076462847 Truabutment Korea Co.,Ltd	TRU RATCHET DRIVER	2025-10-02
GUDID 08800076462830 Truabutment Korea Co.,Ltd	TRU RATCHET DRIVER	2025-10-02
GUDID 08800076462823 Truabutment Korea Co.,Ltd	TRU RATCHET DRIVER	2025-10-02
GUDID 08800076462816 Truabutment Korea Co.,Ltd	TRU RATCHET DRIVER	2025-10-02
GUDID 08800076462809 Truabutment Korea Co.,Ltd	TRU RATCHET DRIVER	2025-10-02
GUDID 08800076422711 Truabutment Korea Co.,Ltd	Fixture Driver	2025-10-02
GUDID 08800076422704 Truabutment Korea Co.,Ltd	Fixture Driver	2025-10-02
GUDID 08800076422698 Truabutment Korea Co.,Ltd	Fixture Driver	2025-10-02
GUDID 08800076422681 Truabutment Korea Co.,Ltd	Fixture Driver	2025-10-02
GUDID 08800076422674 Truabutment Korea Co.,Ltd	Fixture Driver	2025-10-02
GUDID 08800076422667 Truabutment Korea Co.,Ltd	Fixture Driver	2025-10-02
GUDID 08800076418417 Truabutment Korea Co.,Ltd	AOT Straight Driver	2025-10-02
GUDID 08800076418400 Truabutment Korea Co.,Ltd	AOT Straight Driver	2025-10-02
GUDID 08800076418301 Truabutment Korea Co.,Ltd	AOT Straight Driver	2025-10-02
GUDID 08800076417939 Truabutment Korea Co.,Ltd	T-L Straight Driver	2025-10-02
GUDID 08800076417809 Truabutment Korea Co.,Ltd	Fixture Driver	2025-10-02
GUDID 08800076417793 Truabutment Korea Co.,Ltd	Fixture Driver	2025-10-02
GUDID 08800076417786 Truabutment Korea Co.,Ltd	Fixture Driver	2025-10-02
GUDID 08800076417779 Truabutment Korea Co.,Ltd	Fixture Driver	2025-10-02
GUDID 08800076417762 Truabutment Korea Co.,Ltd	Fixture Driver	2025-10-02
GUDID 08800076417755 Truabutment Korea Co.,Ltd	Fixture Driver	2025-10-02
GUDID 08800076417748 Truabutment Korea Co.,Ltd	Fixture Driver	2025-10-02
GUDID 08800076417731 Truabutment Korea Co.,Ltd	Fixture Driver	2025-10-02
GUDID 08800076417724 Truabutment Korea Co.,Ltd	Fixture Driver	2025-10-02
GUDID 08800076417717 Truabutment Korea Co.,Ltd	Fixture Driver	2025-10-02
GUDID 08800076417700 Truabutment Korea Co.,Ltd	Fixture Driver	2025-10-02
GUDID 08800076417694 Truabutment Korea Co.,Ltd	Fixture Driver	2025-10-02
GUDID 08800076417687 Truabutment Korea Co.,Ltd	Fixture Driver	2025-10-02
GUDID 08800076417670 Truabutment Korea Co.,Ltd	Fixture Driver	2025-10-02
GUDID 08800076417663 Truabutment Korea Co.,Ltd	Fixture Driver	2025-10-02
GUDID 08800076417656 Truabutment Korea Co.,Ltd	Fixture Driver	2025-10-02
GUDID 08800076417649 Truabutment Korea Co.,Ltd	Fixture Driver	2025-10-02
GUDID 08800076417632 Truabutment Korea Co.,Ltd	Fixture Driver	2025-10-02
GUDID 08800076417625 Truabutment Korea Co.,Ltd	Fixture Driver	2025-10-02
GUDID 08800076417618 Truabutment Korea Co.,Ltd	Fixture Driver	2025-10-02
GUDID 08800076441729 Truabutment Korea Co.,Ltd	Tru Ratchet Driver	2025-10-01
GUDID 08800076441712 Truabutment Korea Co.,Ltd	TRU 4-WAY DRIVER	2025-10-01
GUDID 08800076441705 Truabutment Korea Co.,Ltd	TRU 4-WAY DRIVER	2025-10-01
GUDID 08800076441699 Truabutment Korea Co.,Ltd	TRU 4-WAY DRIVER	2025-10-01
GUDID 08800076431652 Truabutment Korea Co.,Ltd	Tru 2-way Driver	2025-10-01
GUDID 08800076424159 Truabutment Korea Co.,Ltd	ASC Driver	2025-10-01
GUDID 08800076418394 Truabutment Korea Co.,Ltd	TRU 4-WAY DRIVER	2025-10-01
GUDID 08800076418387 Truabutment Korea Co.,Ltd	Tru 2-way Driver	2025-10-01
GUDID 08800076418363 Truabutment Korea Co.,Ltd	Tru 2-way Driver	2025-10-01
GUDID 08800076418356 Truabutment Korea Co.,Ltd	Tru 2-way Driver	2025-10-01
GUDID 08800076418349 Truabutment Korea Co.,Ltd	Tru 2-way Driver	2025-10-01
GUDID 08800076417922 Truabutment Korea Co.,Ltd	ASC Driver	2025-10-01
GUDID 08800076417915 Truabutment Korea Co.,Ltd	ASC Driver	2025-10-01
GUDID 08800076417908 Truabutment Korea Co.,Ltd	ASC Driver	2025-10-01
GUDID 08800076417892 Truabutment Korea Co.,Ltd	ASC Driver	2025-10-01
GUDID 08800076417885 Truabutment Korea Co.,Ltd	ASC Driver	2025-10-01
GUDID 08800076417878 Truabutment Korea Co.,Ltd	ASC Driver	2025-10-01
GUDID 08800076417861 Truabutment Korea Co.,Ltd	ASC Driver	2025-10-01
GUDID 08800076417854 Truabutment Korea Co.,Ltd	ASC Driver	2025-10-01
GUDID 08800076417588 Truabutment Korea Co.,Ltd	TruDriver Handle	2025-10-01
GUDID 08800076417571 Truabutment Korea Co.,Ltd	TruDriver Handle	2025-10-01
GUDID 08800076417564 Truabutment Korea Co.,Ltd	TruDriver Handle	2025-10-01
GUDID 08800076417557 Truabutment Korea Co.,Ltd	TruDriver Handle	2025-10-01
GUDID 08800076417540 Truabutment Korea Co.,Ltd	TruDriver Handle	2025-10-01
GUDID 08800076417533 Truabutment Korea Co.,Ltd	TruDriver Handle	2025-10-01
GUDID 08800076417526 Truabutment Korea Co.,Ltd	TruDriver Handle	2025-10-01
GUDID 08800076417519 Truabutment Korea Co.,Ltd	TruDriver Handle	2025-10-01
GUDID 08800076417502 Truabutment Korea Co.,Ltd	TruDriver Handle	2025-10-01
GUDID 08800076417496 Truabutment Korea Co.,Ltd	TruDriver Handle	2025-10-01
GUDID 08800076417489 Truabutment Korea Co.,Ltd	TruDriver Handle	2025-10-01
GUDID 08800076417472 Truabutment Korea Co.,Ltd	TruDriver Handle	2025-10-01
GUDID 08800076417465 Truabutment Korea Co.,Ltd	TruDriver Handle	2025-10-01
GUDID 08800076417458 Truabutment Korea Co.,Ltd	TruDriver Handle	2025-10-01
GUDID 08800076417441 Truabutment Korea Co.,Ltd	TruDriver Handle	2025-10-01
GUDID 08800076417434 Truabutment Korea Co.,Ltd	TruDriver Handle	2025-10-01
GUDID 08800076417427 Truabutment Korea Co.,Ltd	TruDriver Handle	2025-10-01
GUDID 08800076417410 Truabutment Korea Co.,Ltd	TruDriver Handle	2025-10-01
GUDID 08800076417403 Truabutment Korea Co.,Ltd	TruDriver Handle	2025-10-01
GUDID 08800076417397 Truabutment Korea Co.,Ltd	TruDriver Handle	2025-10-01
GUDID 08800076417380 Truabutment Korea Co.,Ltd	TruDriver Handle	2025-10-01
GUDID 08800076417373 Truabutment Korea Co.,Ltd	TruDriver Handle	2025-10-01
GUDID 08800076417366 Truabutment Korea Co.,Ltd	TruDriver Handle	2025-10-01
GUDID 08800076417359 Truabutment Korea Co.,Ltd	TruDriver Handle	2025-10-01
GUDID 08800076417342 Truabutment Korea Co.,Ltd	TruDriver Handle	2025-10-01
GUDID 08800076417335 Truabutment Korea Co.,Ltd	TruDriver Handle	2025-10-01
GUDID 08800076417328 Truabutment Korea Co.,Ltd	TRU 4-WAY DRIVER	2025-10-01
PMN K172100 | NHA TruAbutment Korea Co., Ltd.	URIS OMNI System	2018-09-12
PMN K172100 | DZE TruAbutment Korea Co., Ltd.	URIS OMNI System	2018-09-12
PMN K171532 | NHA TruAbutment Korea Co., Ltd.	TruBase S	2018-09-12
PMN K172304 | NHA TruAbutment Korea Co., Ltd.	TruAbutment DS	2018-01-23
PMN K170259 | NHA TruAbutment Korea Co., Ltd.	TruAbutment DS	2018-01-23
NDP TruAbutment Korea Co., Ltd.	URIS Scanbody Reguar	2016-12-16
NDP TruAbutment Korea Co., Ltd.	URIS Scanbody Narrow	2016-12-16
NDP TruAbutment Korea Co., Ltd.	TruScanbody	2016-12-16
NDP TruAbutment Korea Co., Ltd.	TruGUIDE Sleeve Pushing Jig	2016-12-16
NDP TruAbutment Korea Co., Ltd.	TruGUIDE Kit(TRUGKITCG2)	2016-12-16
NDP TruAbutment Korea Co., Ltd.	TruGUIDE Kit Tissue Punch	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Torque Wrench	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Titanium Bowl	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Tissue Punch	2016-12-16
NDP TruAbutment Korea Co., Ltd.	T LOC Component	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Surgical Kit (SKA 01)	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Removal Driver	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Pylon Sleeve	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Pylon Plus Kit (PPK 01)	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Pylon Kit (NKA 01)	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Pylon Crestal Sinus Kit (PSK 01)	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Pylon Anchor Kit (PAK 01)	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Protective Cap	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Path Pin	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Parallel Pin	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Multi-Unit Scan Body	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Multi-Unit Impression Post Transfer	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Multi-Unit Impression Post Pick-Up	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Multi Unit Analog	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Multi Unit Abut. Driver	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Membrane Elevator	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Membrane Elevator Tube	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Membrane Elevator Carrier	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Lab Analog_Fixture Level	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Lab Analog_Abutment Level	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Impression Post Transfer	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Impression Post Pick-up	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Impression Cap	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Hex Driver	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Fixture Driver	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Fixation Screw	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Fixation Pin	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Extension Adapter	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Drill Extension	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Depth Gauge	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Dental Accessories	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Bone Condenser	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Bone Condenser Handle	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Ball Abutment Driver	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Ball Abutment Analog	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Angle Screw Channel Driver	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Anchor Pin	2016-12-16
NDP TruAbutment Korea Co., Ltd.	Anchor Driver	2016-12-16
NDP TruAbutment Korea Co., Ltd.	ASC Kit(ASC 01)	2016-12-16
DZA TruAbutment Korea Co., Ltd.	TruGUIDE Kit Twist Drill	2016-12-16
DZA TruAbutment Korea Co., Ltd.	TruGUIDE Kit Taper Drill	2016-12-16
DZA TruAbutment Korea Co., Ltd.	TruGUIDE Kit Reamer	2016-12-16
DZA TruAbutment Korea Co., Ltd.	TruGUIDE Kit Point Drill	2016-12-16
DZA TruAbutment Korea Co., Ltd.	Step Drill	2016-12-16
DZA TruAbutment Korea Co., Ltd.	Socket Drill	2016-12-16
DZA TruAbutment Korea Co., Ltd.	Sinus Drill	2016-12-16
DZA TruAbutment Korea Co., Ltd.	Side Cut Drill	2016-12-16
DZA TruAbutment Korea Co., Ltd.	Round Drill	2016-12-16
DZA TruAbutment Korea Co., Ltd.	Point Drill	2016-12-16
DZA TruAbutment Korea Co., Ltd.	Pilot Drill	2016-12-16
DZA TruAbutment Korea Co., Ltd.	Path Drill	2016-12-16
DZA TruAbutment Korea Co., Ltd.	Initial Drill	2016-12-16
DZA TruAbutment Korea Co., Ltd.	Flat Drill	2016-12-16
DZA TruAbutment Korea Co., Ltd.	Final Drill	2016-12-16
DZA TruAbutment Korea Co., Ltd.	Dental Drills	2016-12-16
DZA TruAbutment Korea Co., Ltd.	Bone Profiler	2016-12-16
DZA TruAbutment Korea Co., Ltd.	Anchor Drill	2016-12-16
PMN K152559 | NHA TruAbutment Korea Co., Ltd.	TruAbutment DS	2016-07-19

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092254806	Pusan,South Korea -> Long Beach, California	ROLL LABEL	1 PKG
2020080668963	Pusan,South Korea -> Long Beach, California	RACK	7 PKG