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FDA 510(k) Applications Submitted by Su Hyun Park
FDA 510(k) Number
Submission Date
Device Name
Applicant
K240574
03/01/2024
BruxZir« Radiant
Prismatik Dentalcraft, Inc.
K220493
02/22/2022
Plaxpot Multi Plasma
GCS Co. Limited
K202418
08/24/2020
Magic UCLA Abutment System
InnoBioSurg Co., Ltd.
K203344
11/13/2020
Premilled Titanium Block System
InnoBioSurg Co., Ltd.
K152877
09/30/2015
SureFine Pen Needle
SHINA MED CORPORATION
K152879
09/30/2015
Sure-Fine Insulin Syringes
SHINA MED CORPORATION
K140091
01/14/2014
XPEED ANYRIDGE INTERNAL IMPLANT SYSYEM
MEGAGEN IMPLANT CO., LTD
K132178
07/15/2013
MOSTDI DENTAL IMPLANT SYSTEM
MOSTDI INNOVATIONS SDN BHD
K132242
07/18/2013
INNO SLA SUBMERGED IMPLANT SYSTEM
COWELLMEDI CO., LTD
K132956
09/20/2013
U FIT DENTAL IMPLANT SYSTEM
T STRONG, INC
K170983
04/03/2017
NIOX VERO
Circassia AB
K093508
11/12/2009
RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12)
WOMANCARE GLOBAL
K133898
12/20/2013
NIOX VERO AIRWAY INFLAMMATION MONITOR
AEROCRINE AB
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