FDA 510(k) Applications Submitted by Young Seok Kim
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K102131 |
07/29/2010 |
NANO-CHECK AMI CTNI CARDIAC MARKER TEST |
NANO-DITECH CORPORATION |
| K211108 |
04/14/2021 |
Prudent 1717, Prudent 1417, Prudent 1212 |
PIXXGEN Corporation |
| K213933 |
12/16/2021 |
Percent Oxygen Sensors |
CareOx, LLC |
| K231079 |
04/17/2023 |
LW Retraction Cap |
Ossvis Co., Ltd. |
| K231235 |
04/28/2023 |
LW UCLA Abutment |
Ossvis Co., Ltd. |
| K223924 |
12/30/2022 |
LW Implant System |
Ossvis Co., Ltd. |
| K221817 |
06/22/2022 |
ALFIS Vitamin D, ALFIS-3 Analyzer |
Immunostics Inc. |
| K220003 |
01/04/2022 |
EzOrtho v1.3 |
Ewoosoft Co., Ltd |
| K190087 |
01/17/2019 |
EzDent-i / E2 / Prora View |
EWOO SOFT Co., Ltd. |
| K200178 |
01/24/2020 |
Ez3D-i /E3 |
Ewoosoft Co., Ltd. |
| K230468 |
02/21/2023 |
EzDent Web |
Ewoosoft Co., Ltd |
| K150761 |
03/23/2015 |
Ez3D-i/E3 |
EWOO SOFT CO., LTD |
| K190791 |
03/27/2019 |
Ez3D-i/E3 |
EwooSoft Co., Ltd. |
| K161117 |
04/20/2016 |
EzDent-i / E2 / Prora View |
EWOO SOFT CO., LTD. |
| K161246 |
05/03/2016 |
Ez3D-i / E3 |
EWOO SOFT CO., LTD. |
| K211700 |
06/03/2021 |
EzDent Web |
Ewoosoft Co., Ltd |
| K211795 |
06/10/2021 |
EzDent-i/ E2/ Prora View/ Smart M Viewer |
Ewoosoft Co., Ltd. |
| K211793 |
06/10/2021 |
EzOrtho |
Ewoosoft Co., Ltd |
| K211791 |
06/10/2021 |
Ez3D-i/E3 |
Ewoosoft Co., Ltd |
| K231757 |
06/16/2023 |
Ez3D-i /E3 |
Ewoosoft Co., Ltd |
| K222069 |
07/14/2022 |
Ez3D-i/E3 |
Ewoosoft Co., Ltd |
| K222145 |
07/20/2022 |
EzDent-i / E2 / Prora View/ Smart M Viewer |
Ewoosoft Co., Ltd |
| K202116 |
07/30/2020 |
EzDent-i/ E2/ Prora View/ Smart M Viewer |
Ewoo soft Co., Ltd. |
| K172364 |
08/04/2017 |
EzDent-i / E2 / Prora View |
Ewoo Soft Co., Ltd. |
| K192098 |
08/05/2019 |
EzMobile |
Ewoosoft Co., Ltd. |
| K152746 |
09/23/2015 |
Ez3D Plus |
EWOO SOFT CO., LTD. |
| K173094 |
09/29/2017 |
OrthoVision |
Ewoo Soft Co., Ltd. |
| K202948 |
09/30/2020 |
EzOrtho |
Ewoo Soft Co., Ltd. |
| K192888 |
10/10/2019 |
EzOrtho |
Ewoo Soft Co., Ltd. |
| K163539 |
12/16/2016 |
Ez3D-i / E3 |
EWOO SOFT Co., Ltd. |
| K163533 |
12/16/2016 |
EzDent-i; E2; ProraView |
EWOO SOFT CO., LTD. |
| K173863 |
12/20/2017 |
Ez3D-i /E3 |
Ewoo Soft Co., Ltd. |
| K223820 |
12/21/2022 |
EzDent-i / E2 / Prora View/ Smart M Viewer |
Ewoosoft Co., Ltd |
| K102441 |
07/29/2010 |
NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN |
NANO-DITECH CORPORATION |
| K140234 |
01/29/2014 |
ASPIRON ACP SYSTEM |
U&I CORP. |
| K150570 |
03/06/2015 |
ANAX OCT Spinal System |
U&I Corporation |
| K132101 |
07/08/2013 |
ANAX 5.5 SPINAL SYSTEM |
U & I CORPORATION |
| K132218 |
07/17/2013 |
PERFIX ILIAC SCREW SYSTEM |
U & I CORPORATION |
| K222838 |
09/20/2022 |
iSyncBrain⌐-C |
iMediSync Inc. |
| K143417 |
11/28/2014 |
ANAX 5.5 Spinal System |
U&I Corporation |
| K143631 |
12/22/2014 |
Benefix Interspinous Fixation System |
U & I Corporation |
| K222245 |
07/26/2022 |
ACR Screw System |
BioMaterials Korea, Inc |
| K190830 |
04/01/2019 |
TDM Screw Systems |
TDM Co. Ltd. |
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