Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012422333

FEI Number

3012422333

Entity Name

TruAbutment Korea Co., Ltd.

City/State/Country

Bucheon-si Gyeonggi, KR

Establishment Address

104-214~216, 101-1308~1309, 397, Seokcheon-ro, Bucheon-si Gyeonggi 14449, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TRUABUTMENT KOREA CO., LTD. (Owner Number: 10052347)

Owner / Operator Contact Address

104-214~216, 101-1308~1309, 397, Seokcheon-ro,, Bucheon-si, KR-41 14449, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K152559

PMA Number

N/A

All Registered Proprietary Names

TruAbutment DS Direct Screw Initial Reamer Direct Screw Reamer Stopper Tru Reamer Kit Base Reamer Direct Screw Final Reamer Cone Reamer TruAbutment DS TruBase TruAbutment DS AOT & T-L Abutment TruAbutment DS 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 TruAbutment DS TruAbutment DS URIS Long Implant & Abutments TruAbutment DS, TruBase URIS OMNI Implant TruAbutment DS TruAbutment DS TruAbutment DS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2020-09-01
EJL	Bur, Dental	Dental	Class 1	872.3240	2025-04-10
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2023-01-10
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2020-10-18
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-03-28
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-10-26
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2016-12-16
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-01-23
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-09-12
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2025-07-07
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-07-07
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-10-17
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2018-09-12
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-09-12
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-10-26
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-01-23
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2016-07-19

Official Correspondent

Hyuk yong Lee

US Agent Details

Chris Choi Business: TruAbutment Inc. Email: chris.choi@truabutment.com Phone: (714) 7675123

Related Public Records

Same Entity

TRUABUTMENT KOREA CO., LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18
K081806	Idi Biomedical, LLC	IDI IMPLANT SYSTEM	2008-11-07
K120793	Z-Systems AG	Z-LOOK3 EVO SLM	2012-12-21
K130140	Intra-Lock International	INTRA-LOCK OP DENTAL IMPLANT	2013-08-01
K925778	Nobelpharma USA, Inc.	BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES	1993-04-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2018	Implant Direct Sybron Manufacturing, LLC	2	Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Z-0010-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Z-0017-2026	S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil	2	IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N
Z-0018-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0019-2020	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	2	Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012422333. Last updated year: 2026. Please use registration number 3012422333 when referencing this establishment in official correspondence.