FDA.reportPublic FDA data

OSSTEM IMPLANT CO., LTD.

Matched from indexed company URL: 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
30159802073015980207OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS1N2026-01-01192, Haebong-ro, Danwon-gu Ansan-si Gyeonggi KR 15428
30458169483045816948OSSTEM IMPLANT CO.,LTD.1N2026-01-01104 Cheomdan-daero Yeonsu-gu Incheon KR 21989
30124111083012411108OSSTEM IMPLANT Co., Ltd. Chair Business1N2020-04-25135 Gasan digital 2-ro, Geumcheon-gu Seoul Seoul Teugbyeolsi KR 08504

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
08800000996042T2 Plus - T2 PLUS is a digital X-ray CT, panoramic, and Cephalo imaging system device composed of X-ray generator, X-ray controller, X-ray supporter, image processing unit(sensor), PC, and software. The apparatus attached to the equipment column is a structure that can be rotated 360 degree by the system control unit. This system control unitactuates the motor control, X-ray generator, and image processing unit (sensor). The height controlling unit controls the column and adjusts the height of the equipment. TheX-ray generator and image processing unit (sensor) are attached to the rotating apparatus. When the rotating apparatus starts the rotation, X-ray is irradiated from the X-ray generator (generating unit). This X-ray irradiation penetrates the subject and reaches the image processing unit (sensor), and then is converted into electric signals to secureimagery information. Inside the imaging section of the image processing unit (sensor), real time X-ray input is converted into electric signals and consecutively combined, resulting in imagery information. The combined panoramic imagery information is then sent to the PC and saved in patient management software.+1 (201) 266 0657mateusz.leszczak@hiossen.com
08800000996059T2 Plus - T2 PLUS is a digital X-ray CT, panoramic, and Cephalo imaging system device composed of X-ray generator, X-ray controller, X-ray supporter, image processing unit(sensor), PC, and software. The apparatus attached to the equipment column is a structure that can be rotated 360 degree by the system control unit. This system control unitactuates the motor control, X-ray generator, and image processing unit (sensor). The height controlling unit controls the column and adjusts the height of the equipment. TheX-ray generator and image processing unit (sensor) are attached to the rotating apparatus. When the rotating apparatus starts the rotation, X-ray is irradiated from the X-ray generator (generating unit). This X-ray irradiation penetrates the subject and reaches the image processing unit (sensor), and then is converted into electric signals to secureimagery information. Inside the imaging section of the image processing unit (sensor), real time X-ray input is converted into electric signals and consecutively combined, resulting in imagery information. The combined panoramic imagery information is then sent to the PC and saved in patient management software.+1 (201) 266 0657mateusz.leszczak@hiossen.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3508641261375697K950532TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHYEAP1995-04-19
2343011732929357K950532TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHYEAP1995-04-19
227911231201117K251569Bone ScrewDZL2025-08-13
2343011616907208K251491K5 Cart, K5 Mount, K5 SwingEIA2025-07-17
3508641647278569K251491K5 Cart, K5 Mount, K5 SwingEIA2025-07-17
227911262179178K251434Healing Abutment SystemNHA2026-03-04
2274052031532743K242521Estar-ZEEIH2024-11-20
3508641857866909K233806T2 PlusOAS2024-09-06
2343011126532038K233805K5EIA2024-09-03
3508641616838886K233805K5EIA2024-09-03
227911942384476K233194TS Abutment SystemNHA2024-02-20
227911640636943K232220SS Abutment SystemNHA2023-12-05
3508641024000705K232012N1EHD2023-11-28
227911914885770K222778Osstem Implant SystemDZE2023-09-23
227911157295791K221684Osstem Abutment SystemNHA2022-09-08
3508641155924234K212303T2OAS2021-09-21
2274051860901266K210097Estar-ZEIH2021-07-02
2274051837244161K210041HySil Plus Impression MaterialsELW2021-03-18
2274051343788402K192941HySil Super Fast Impression MaterialsELW2020-01-30
227911343788402K192941HySil Super Fast Impression MaterialsELW2020-01-30
3508641116705214K183475T1-CS, T1-COAS2019-08-30
3508641858553116K183347K3EIA2019-09-04
2343011893019016K183347K3EIA2019-09-04
1885161893019016K183347K3EIA2019-09-04
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
1885161419726199K173905Surgic Pro, Surgic Pro+EBW2018-06-19
227912045104948K172354OssBuilder SystemJEY2018-03-26
2274051636296930K170736HySil Impression MaterialsELW2017-06-07
227911636296930K170736HySil 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
2343011186714465K152830K3EIA2017-04-20
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
1885161974052137
227911104194429
227911112647148
227911119649017
227911185887993
227911383187639
3508641451457261
227911467212481
227911500293135
227911659319968
227911674366658
227911700925822
227911754311351
227911799285594
2274051799285594
227911816045823
227911864541977
227911900007281
2343011974052137

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DZE212023-09-23
NHA172026-03-04
EIA82025-07-17
ELW72021-03-18
DZL32025-08-13
OAS32024-09-06
JEY32018-03-26
EIH22024-11-20
OAT22016-12-21
EAP21995-04-19
EHD12023-11-28
EBW12018-06-19

PMN#

68 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next