FDA 510(k) Applications Submitted by CHARLEMAGNE CHUA

FDA 510(k) Number Submission Date Device Name Applicant
K153534 12/09/2015 NobelProcera HT ML Full Contour Zirconia Crown NOBEL BIOCARE AB
K170135 01/17/2017 TREFOIL System Nobel Biocare AB
K160119 01/19/2016 NobelSpeedy Groovy NOBEL BIOCARE AB
K160158 01/27/2016 NobelProcera HT ML FCZ Implant Bridge and Framework Nobel Biocare AB
K180899 04/06/2018 Universal Base Abutment Nobel Biocare AB
K121076 04/09/2012 ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K171142 04/18/2017 Healing Cap Multi-Unit Titanium Nobel Biocare AB
K181075 04/24/2018 PureSet Tray Nobel Biocare AB
K121422 05/14/2012 APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN
K171466 05/18/2017 NobelDesign, DTX Studio Design Nobel Biocare AB
K161416 05/23/2016 Multi-unit Abutment Plus NOBEL BIOCARE AB
K131507 05/24/2013 XARIO 200 DIAGNOSTIC ULTRASOUND SYSTEM TOSHIBA MEDICAL SYSTEMS CORPORATION
K161435 05/24/2016 Temporary Snap Abutment Nobel Biocare AB
K121577 05/30/2012 APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN
K191475 06/04/2019 Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate Nobel Biocare AB
K161598 06/09/2016 NobelZygoma 0░ Nobel Biocare AB
K161634 06/14/2016 IPS CaseDesigner NOBEL BIOCARE AB
K161655 06/16/2016 On1 Concept NOBEL BIOCARE AB
K181869 07/12/2018 On1 Universal Abutment Nobel Biocare AB
K181932 07/19/2018 DTX Studio design Nobel Biocare AB
K162043 07/25/2016 NobelProcera HT ML FCZ Bridge Nobel Biocare AB
K172224 07/25/2017 DTX Studio diagnose Nobel Biocare AB
K172352 08/03/2017 TREFOIL System Nobel Biocare AB
K122491 08/15/2012 VIAMO SSA-640A V4.0 TOSHIBA MEDICAL SYSTEMS CORPORATION
K122613 08/27/2012 VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K122842 09/17/2012 RADREX-I, SW V4.00 MODEL DRAD-3000E TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K172854 09/20/2017 NobelPerfect Abutments Nobel Biocare AB
K152836 09/29/2015 TREFOIL System NOBEL BIOCARE AB
K153036 10/19/2015 NobelDesign Software NOBEL BIOCARE AB
K133277 10/24/2013 XARIO 100 TOSHIBA MEDICAL SYSTEMS CORPORATION
K173418 11/01/2017 NobelParallel Conical Connection Nobel Biocare AB
K183069 11/05/2018 NobelZygoma 0░ Nobel Biocare AB
K133535 11/18/2013 INFX-8000V, V5.30 TOSHIBA MEDICAL SYSTEMS CORPORATION
K133761 12/11/2013 APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM V4.0 TOSHIBA MEDICAL SYSTEMS CORPORATION
K163600 12/21/2016 Kit Boxes and Kit Plates Nobel Biocare AB
K123992 12/26/2012 APLIO 500/400/300 V3.0 TOSHIBA MEDICAL SYSTEMS CORPORATION


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