FDA 510(k) Applications Submitted by Da Hee Kim
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K233659 |
11/15/2023 |
Suture Wing |
OSTEONIC Co., Ltd. |
| K210289 |
02/02/2021 |
Infant Phototherapy Equipment |
Bistos Co., Ltd. |
| K211016 |
04/05/2021 |
Powered Breast Pump (Models 7V and 7X) |
Haenim Co., Ltd. |
| K242719 |
09/10/2024 |
ELEXIR 2.0 (ALLIVE3) |
Nu Eyne Co., Ltd. |
| K243289 |
10/18/2024 |
ADDNOX (BPSPM1) |
Nu Eyne Co., Ltd. |
| K240040 |
01/05/2024 |
VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan) |
VATECH Co., Ltd |
| K170066 |
01/09/2017 |
Green16/Green18 (Model: PHT-65LHS) |
VATECH CO., LTD. |
| K200182 |
01/24/2020 |
EzRay Air Portable (Model: VEX-P300) |
Vatech Co., Ltd |
| K210329 |
02/04/2021 |
Green X 18(Model : PHT-75CHS) |
Vatech Co., Ltd |
| K170731 |
03/10/2017 |
System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight |
Vatech Co., Ltd |
| K160882 |
03/31/2016 |
PaX-i3D Green Premium (Model: PCT-90LH) |
VATECH CO., LTD |
| K161063 |
04/15/2016 |
EzRay Air (Model VEX-P300) |
Vatech Co., Ltd |
| K201627 |
06/16/2020 |
Dental Computed Tomography X-Ray System, Green X |
Vatech Co., Ltd |
| K231796 |
06/20/2023 |
Grreen X 12 (Model: PHT-75CHS) |
Vatech Co., Ltd |
| K152106 |
07/29/2015 |
Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart |
VATECH CO., LTD |
| K162660 |
09/26/2016 |
Green Smart (Model: PHT-35LHS) |
VATECH CO., LTD |
| K223058 |
09/30/2022 |
EzRay Air 2 Wall (Model: VEX-S350W) |
Vatech Co., Ltd |
| K243081 |
09/30/2024 |
Green X 21 (PHT-90CHO) |
VATECH Co., Ltd |
| K213462 |
10/27/2021 |
EzRay M18 (Model: VMX-P400) |
Vatech Co., Ltd |
| K203667 |
12/16/2020 |
EzRay M (Model: VMX-P300) |
Vatech Co., Ltd |
| K203797 |
12/28/2020 |
vatech A9 (Model : PHT-30CSS) |
Vatech Co., Ltd |
| K163705 |
12/29/2016 |
EzRay Air W |
Vatech Co., Ltd |
| K140060 |
01/10/2014 |
DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A |
RAYENCE CO., LTD |
| K140056 |
01/10/2014 |
DIGITAL DENTAL INTRA ORAL SENSOR; HDI 1000, HDI 1000A |
RAYENCE CO., LTD |
| K100317 |
02/04/2010 |
DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMO |
VATECH CO., LTD. |
| K130432 |
02/21/2013 |
PHT-6500, PHT-60CFO |
VATECH CO., LTD. |
| K130585 |
03/05/2013 |
PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM |
VATECH CO., LTD. |
| K140646 |
03/13/2014 |
DIGITAL FLAT PANEL X-RAY DETECTOR / 1717G, XMARU1717G |
RAYENCE CO., LTD |
| K130935 |
04/04/2013 |
DIGITAL FLAT PANEL X-RAY DETECTOR/1417WCA |
RAYENCE CO., LTD |
| K121132 |
04/13/2012 |
EZSENSOR P DIGITAL INTRAORAL SENSOR |
HUMANRAY CO,LTD |
| K131114 |
04/22/2013 |
DIGITAL FLAT PANEL X-RAY DETECTOR |
RAYENCE CO., LTD |
| K121236 |
04/24/2012 |
PAX-DUO3D PLUS, PCT-5000 |
VATECH CO., LTD. |
| K121400 |
05/10/2012 |
PAX-UNI3D, PHT-7500 |
VATECH CO., LTD. |
| K121412 |
05/11/2012 |
PAX-FLEX3D, PHT-7000 |
VATECH CO., LTD. |
| K131570 |
05/30/2013 |
ORTHOVISION |
EWOO SOFT CO., LTD |
| K131594 |
06/03/2013 |
EZDENTI-I; E2; PRORA VIEW |
EWOO SOFT CO., LTD |
| K131616 |
06/03/2013 |
EZ3D-I, E3 |
EWOO SOFT CO., LTD |
| K101590 |
06/07/2010 |
DIGITAL FLAT PANEL X-RAY DETECTOR |
VATECH CO., LTD. |
| K141566 |
06/12/2014 |
SOLID STATE X-RAY IMAGING DEVICE, DIGIITAL FLAT PANEL X-RAY DETECTOR, 1417WCC |
RAYENCE CO., LTD |
| K141563 |
06/12/2014 |
SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC |
RAYENCE CO., LTD |
| K081847 |
06/30/2008 |
PICASSO MASTER, ECT AND MASTER 3D |
E-WOO TECHNOLOGY |
| K081899 |
07/03/2008 |
ANYRAY PORTABLE X-RAY SYSTEM |
E-WOO TECHNOLOGY CO., LTD. |
| K232115 |
07/14/2023 |
TDM Large Bone Plate and Screw System |
TDM CO., LTD |
| K122155 |
07/20/2012 |
PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM |
VATECH CO., LTD. |
| K122182 |
07/23/2012 |
DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC |
RAYENCE CO., LTD |
| K122173 |
07/23/2012 |
DIGITAL FLAT PLANEL X-RAY DETECTOR / 1717SCC |
RAYENCE CO., LTD |
| K102078 |
07/26/2010 |
RADIOLOGICAL IMAGE PROCESSING SYSTEM |
VATECH CO., LTD. |
| K102102 |
07/27/2010 |
COMPUTED TOMOGRAPHY X-RAY SYSTEM |
VATECH CO., LTD. |
| K102196 |
07/29/2010 |
COMPUTED TOMOGRAPHY X-RAY SYSTEM |
VATECH CO., LTD. |
| K102124 |
07/29/2010 |
DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM |
VATECH CO., LTD. |
| K102207 |
08/05/2010 |
FIBER FORCE |
SYNCA MARKETING, INC. |
| K102259 |
08/10/2010 |
DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM |
VATECH CO., LTD. |
| K082350 |
08/15/2008 |
PAX-500 |
VATECH CO., LTD. |
| K102321 |
08/17/2010 |
DIGITAL FLAT PANEL X-RAY DETECTOR MODEL SDX-4336CP |
SAMSUNG MOBILE DISPLAY CO., LTD |
| K122606 |
08/27/2012 |
PHT-6500; PHT-60CFO; PAX-I3D |
MTECH GROUP |
| K112558 |
09/02/2011 |
DIGITAL FLAT PANEL X-RAY DETECTOR |
SAMSUNG MOBILE DISPLAY CO., LTD |
| K102587 |
09/09/2010 |
LLX240AB01 |
SAMSUNG MOBILE DISPLAY CO., LTD |
| K112751 |
09/21/2011 |
SDX-4343CS |
SAMSUNG MOBILE DISPLAY CO., LTD |
| K132983 |
09/23/2013 |
TON-95LH, PAX-I3D ORTHO |
VATECH CO., LTD. |
| K122928 |
09/24/2012 |
DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGA |
RAYENCE CO., LTD |
| K122919 |
09/24/2012 |
DIGITAL FLAT PANEL X-RAY DETECTOR11417PCA |
RAYENCE CO., LTD |
| K123345 |
10/31/2012 |
DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA |
RAYENCE CO., LTD |
| K133409 |
11/07/2013 |
DIGITAL FLAT PANEL X-RAY DETECTOR/ 910SGA |
RAYENCE CO., LTD |
| K123493 |
11/09/2012 |
VEX-S 100W INTRAORAL X-RAY SYSTEM |
VATECH CO., LTD. |
| K113360 |
11/14/2011 |
MEDICAL IMAGE PROCESSING UNIT |
HUMANRAY CO,LTD |
| K133695 |
12/03/2013 |
TITAN 11 |
GEMSS MEDICAL SYSTEMS CO., LTD |
| K113630 |
12/08/2011 |
DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA |
RAYENCE CO., LTD |
| K163467 |
12/12/2016 |
C-Line Orthodontic Ceramic Bracket |
BIOCETEC CO., LTD |
| K113672 |
12/13/2011 |
PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM |
VATECH CO., LTD. |
| K170421 |
02/13/2017 |
ET Hybrid Abutment |
Hiossen Inc. |
| K180527 |
02/28/2018 |
IS3 |
Hiossen, Inc. |
| K151542 |
06/08/2015 |
A-Oss |
HIOSSEN INC. |
| K151626 |
06/17/2015 |
ET III Bio-SA Fixture System |
HiOSSEN Inc. |
| K162390 |
08/26/2016 |
ET Hybrid Abutment |
HIOSSEN INC. |
|
|
