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OSSTEM IMPLANT CO., LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30033940813003394081OSSTEM IMPLANT CO., LTD.1N2026-01-0166-16, Bansong-ro 513beon-gil, Haeundae-gu Busan KR 48002
30153327843015332784OSSTEM IMPLANT CO., LTD.1N2026-01-01A-DONG, 51, MAYU-RO 238BEON-GIL SIHEUNG Gyeonggi KR 15079

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
227911231201117K251569Bone ScrewDZL2025-08-13
227911262179178K251434Healing Abutment SystemNHA2026-03-04
2274052031532743K242521Estar-ZEEIH2024-11-20
227911942384476K233194TS Abutment SystemNHA2024-02-20
227911640636943K232220SS Abutment SystemNHA2023-12-05
227911914885770K222778Osstem Implant SystemDZE2023-09-23
227911157295791K221684Osstem Abutment SystemNHA2022-09-08
2274051860901266K210097Estar-ZEIH2021-07-02
2274051837244161K210041HySil Plus Impression MaterialsELW2021-03-18
227911343788402K192941HySil Super Fast Impression MaterialsELW2020-01-30
2274051343788402K192941HySil Super Fast Impression MaterialsELW2020-01-30
227911807903804K182881Bone Screw, Bone TackDZL2019-08-09
227911457777124K182091Osstem Abutment SystemNHA2019-07-12
227911454246474K181854OssBuilder SystemDZL2019-05-07
227911248564552K181236HySil Impression MaterialsELW2018-09-13
2274051248564552K181236HySil Impression MaterialsELW2018-09-13
227912045104948K172354OssBuilder SystemJEY2018-03-26
227911636296930K170736HySil Impression MaterialsELW2017-06-07
2274051636296930K170736HySil Impression MaterialsELW2017-06-07
227911192598329K163557SS SA FixtureDZE2017-05-15
227911606693636K163088TSIII BA FixtureDZE2017-04-21
227911003659923K161689OSSTEM Implant System - AbutmentNHA2017-05-22
227911918574552K161604OSSTEM Implant SystemDZE2016-10-17
227911866302894K161197Orthodontic ScrewOAT2016-12-21
227911236226580K161103US SA Implant SystemDZE2017-02-02
227911612641590K160670ET US SS Prosthetic systemNHA2017-04-25
227912029193191K160519Link Abutment for CERECNHA2016-10-28
227911285543024K140600SB ANCHORNHA2014-08-21
227911437447969K140507HIOSSEN PROSTHETIC SYSTEMNHA2014-08-20
227911605951178K132067MULTI ANGLED ABUTMENT SYSTEMNHA2013-12-20
227911280015853K130840SMARTBUILDER SYSTEM (SB1)JEY2013-09-18
227911400479199K130662ET PROSTHETIC SYSTEMNHA2014-01-10
227911706721049K123755MULTI ANGLED ABUTMENTNHA2013-04-26
227911895307371K122171MS SA IMPLANT SYSTEMDZE2012-11-16
227911448395556K121995TS FIXTURE SYSTEMDZE2012-11-29
227911326786319K121843NP-CAST ABUTMENT SYSTEMNHA2012-12-11
227911353073767K121585TS IMPLANT SYSTEMDZE2013-01-07
227911995795718K120951SMARTBUILDER SYSTEMJEY2012-10-03
227911475424564K120847ET/SS IMPLANT SYSTEMDZE2012-08-10
227911484284470K110308PROSTHETIC SYSTEMNHA2011-10-03
227911005990940K103105ORTHODONTIC SCREWOAT2011-03-25
227912011057424K100245HS/HG PROSTHETIC SYSTEMNHA2010-08-17
227911209178714K091678HG II SHORT FIXTURE SYSTEMDZE2010-02-18
227911905366555K091208GS III SYSTEMDZE2010-03-03
227911314248765K081575HU/HS/HG PROSTHETIC SYSTEMNHA2008-09-02
227911600156446K080744HG II FIXTURE SYSTEMDZE2008-07-17
227911498538711K080594MS SYSTEM (NARROW RIDGE)DZE2008-09-03
227911616355329K073247US/SS/GS SYSTEMDZE2008-03-07
227911282445144K072896GS FIXTURE SYSTEMDZE2007-11-06
227911549407158K072871MS SYSTEM (PROVISIONAL)DZE2008-01-10
227911545057978K063861GS SYSTEMDZE2007-09-21
227911821007095K062156SUPER ORTHODONTIC SCREWDZE2006-10-20
227911340508410K062051SS SYSTEMDZE2006-11-01
227911148697490K062030US SYSTEMDZE2006-11-02
227911270007451K051576AVANA DENTAL IMPLANT SYSTEMDZE2005-09-01
227911745567737
227911104194429
227911112647148
227911119649017
227911185887993
227911383187639
227911467212481
227911500293135
227911659319968
227911674366658
227911700925822
227911754311351
227911799285594
2274051799285594
227911816045823
227911864541977
227911900007281

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DZE212023-09-23
NHA172026-03-04
ELW72021-03-18
DZL32025-08-13
JEY32018-03-26
EIH22024-11-20
OAT22016-12-21

PMN#

GUDID#

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