FDA.reportPublic FDA data

TruAbutment Korea Co., Ltd.

Matched from indexed company URL: TRUABUTMENT INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30124223333012422333TruAbutment Korea Co., Ltd.1N2026-01-01104-214~216, 101-1308~1309, 397, Seokcheon-ro Bucheon-si Gyeonggi KR 14449
30124226933012422693TRUABUTMENT INC.1Y2026-01-0117666 Fitch Irvine CA US 92614

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1970221050035925K243255URIS Long Implant & AbutmentsDZE2025-07-03
1970221154534816K241485TruAbutment DS; TruBaseNHA2024-10-09
2014861170142406K241485TruAbutment DS; TruBaseNHA2024-10-09
1970221156247737K231874AOT & T-L AbutmentNHA2023-10-30
1970221115471223K230438URIS Smart Path Implant System & ProstheticDZE2023-12-29
1970221137457220K213961TruAbutment DS, TruBaseNHA2022-07-14
2014861246927713K213961TruAbutment DS, TruBaseNHA2022-07-14
1970221196095102K203649TruAbutment DS, TruBaseNHA2021-09-15
2014862037250339K203649TruAbutment DS, TruBaseNHA2021-09-15
2014861408057113K202579TruAbutment DS, TruBaseNHA2021-07-08
1970221832898402K202579TruAbutment DS, TruBaseNHA2021-07-08
1970221593830820K201842TruBase SNHA2021-06-04
1970221039698496K201197TruAbutment DS, TruBase SNHA2021-03-26
2014861898304138K201197TruAbutment DS, TruBase SNHA2021-03-26
1970221153431027K200817URIS OMNI Narrow System & ProstheticDZE2020-10-07
1970221137168151K191913TruAbutment DSNHA2020-06-19
2014861254455674K191913TruAbutment DSNHA2020-06-19
2014861148328391K183106TruAbutment DSNHA2020-01-29
1970221570798596K183106TruAbutment DSNHA2020-01-29
2014861392171750K172304TruAbutment DSNHA2018-01-23
1970221796750437K172304TruAbutment DSNHA2018-01-23
1970221999814937K172100URIS OMNI SystemDZE2018-05-04
1970221596201288K171532TruBase SNHA2018-09-11
1970221006571523K170259TruAbutment DSNHA2017-05-25
2014861697009194K170259TruAbutment DSNHA2017-05-25
1970221224193276K152559TruAbutment DSNHA2016-05-20
2014861346558151K152559TruAbutment DSNHA2016-05-20
1970221899992566
1970222027400356
2014861241513229
1970221281535032

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NHA272024-10-09
DZE52025-07-03

PMN#

GUDID#

196 records. Showing 1-40. Next