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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