FDA 510(k) Applications Submitted by NOBEL BIOCARE AB

FDA 510(k) Number Submission Date Device Name Applicant
K163122 11/08/2016 NobelClinician, DTX Studio implant NOBEL BIOCARE AB
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
K171142 04/18/2017 Healing Cap Multi-Unit Titanium Nobel Biocare AB
K171466 05/18/2017 NobelDesign, DTX Studio Design Nobel Biocare AB
K161416 05/23/2016 Multi-unit Abutment Plus NOBEL BIOCARE AB
K161435 05/24/2016 Temporary Snap Abutment 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
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
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
K163600 12/21/2016 Kit Boxes and Kit Plates Nobel Biocare AB
K050393 02/16/2005 THE GUIDED SURGERY CONCEPT NOBEL BIOCARE AB
K050406 02/17/2005 NOBELSPEEDY IMPLANTS NOBEL BIOCARE AB
K030685 03/05/2003 TEETH IN AN HOUR - ARK IMPLANT CONCEPT NOBEL BIOCARE AB
K031070 04/04/2003 CARBON FIBER BRIDGE, MODEL 28757 NOBEL BIOCARE AB
K041236 05/11/2004 PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052 NOBEL BIOCARE AB
K041283 05/13/2004 PROCERA BRIDGE ZIRCONIA NOBEL BIOCARE AB
K031719 06/03/2003 ESTHETIC ZIRCONIA ABUTMENT NOBEL BIOCARE AB
K032562 08/20/2003 PROCEARA COPINGS AND PONTIC NOBEL BIOCARE AB
K043042 11/04/2004 PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052 NOBEL BIOCARE AB
K090069 01/12/2009 PROCERA IMPLANT BRIDGE OVERDENTURE NOBEL BIOCARE AB
K070182 01/19/2007 ZYGOMA IMPLANT (IMMEDIATE FUNCTION) NOBEL BIOCARE AB
K050258 02/03/2005 GROOVY IMPLANTS NOBEL BIOCARE AB
K100512 02/22/2010 NOBELPROCERA IPS E.MAX CROWN NOBEL BIOCARE AB
K090630 03/09/2009 NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION) NOBEL BIOCARE AB
K050705 03/18/2005 TIUNITE IMPLANTS NOBEL BIOCARE AB
K061003 04/11/2006 SFB & CFB IMPLANTS NOBEL BIOCARE AB
K111581 06/07/2011 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 1.5MM, 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 3MM, 15 ESTHETIC ABUTMENT NOBELACTIVE NOBEL BIOCARE AB
K091756 06/16/2009 NOBELPROCERA TI ABUTMENT NOBEL BIOCARE AB
K101714 06/18/2010 NOBELPROCERA TI ABUTMENT THOMMEN PLATFORMS NOBEL BIOCARE AB
K091848 06/22/2009 NOBEL/PROCERA IMPLANT BRIDGE NOBEL BIOCARE AB
K091904 06/25/2009 NOBELPROCERA ZI ABUTMENT NOBEL BIOCARE AB
K091907 06/25/2009 NOBELPROCERA IMPLANT BRIDGE ZIRCONIA NOBEL BIOCARE AB
K061971 07/12/2006 ZIRCONIA IMPLANT NOBEL BIOCARE AB
K072129 08/02/2007 NOBELACTIVE ZIRCONIA ABUTMENT NOBEL BIOCARE AB
K112259 08/08/2011 NOBELACTIVE 3.0 GOLDADAPT ABUTMENTS NOBEL BIOCARE AB
K102436 08/26/2010 NOBEL ACTIVE 3.0 NOBEL BIOCARE AB
K072570 09/12/2007 NOBELACTIVE MULTI UNIT ABUTMENT NOBEL BIOCARE AB
K062749 09/14/2006 SBF 15 ESTHETIC ABUTMENT 1MM NP, MODEL 33699, SFB 15 ESTHETIC ABUTMENT 1MM RP, MODEL 33701, CFB 15 ESTHETIC ABUTMENT 2MM NOBEL BIOCARE AB
K083205 10/30/2008 NOBELACTIVE 8.5 MM & 18.0 MM NOBEL BIOCARE AB
K063592 12/04/2006 ADAPTER PS RP-NP, 34551, ADAPTER PS WP-RP,34552, ABUTMENT SCREW PS RP-NP, 34553, ABUTMENT SCREW PS WP-RP, 34554 NOBEL BIOCARE AB
K063718 12/14/2006 SFB AND CFB IMPLANTS - 5.0 PLATFORM NOBEL BIOCARE AB
K053602 12/23/2005 PROCERA SOFTWARE, MODEL 33145 NOBEL BIOCARE AB
K152093 07/28/2015 NobelZygoma 45? NOBEL BIOCARE AB
K072980 10/23/2007 NOBELPERFECT CONICAL CONNECTION HEXAGONAL IMPLANTS NOBEL BIOCARE AB
K022562 08/02/2002 VARIOUS BRANEMARK SYSTEM IMPLANTS-IMMEDIATE FUNCTION INDICATION NOBEL BIOCARE AB
K133377 11/04/2013 NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT REPLACE NOBEL BIOCARE AB
K123976 12/26/2012 NOBELCLINICIAN NOBEL BIOCARE AB
K070857 03/28/2007 NOBELDIRECT 3.0-IMMEDIATE LOAD, 3.0 X 13 MM AND 3.0 X 15 MM NOBEL BIOCARE AB
K071182 04/30/2007 PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013 NOBEL BIOCARE AB
K071370 05/16/2007 NOBELACTIVE INTERNAL CONNECTION IMPLANT NOBEL BIOCARE AB
K061477 05/30/2006 MULTI-UNIT ABUTMENTS FOR ASTRATECH, CAMLOG AND ANKYLOS IMPLANT SYSTEMS NOBEL BIOCARE AB
K061478 05/30/2006 PROCERA TITANIUM ABUTMENT FOR ASTRATECH AND CAMLOG IMPLANT SYSTEMS NOBEL BIOCARE AB
K061529 06/02/2006 PROCERA ZIRCONIA ABUTMENT FOR CAMLOG IMPLANT SYSTEM NOBEL BIOCARE AB
K142260 08/14/2014 NobelActive NOBEL BIOCARE AB
K122602 08/27/2012 NOBELPROCERA TI ABUTMENT CAMLOG PLATFORMS NOBEL BIOCARE AB
K062936 09/28/2006 NOBELPERFECT CONICAL CONNECTION NOBEL BIOCARE AB
K053050 10/28/2005 PROCERA BRIDGE ALUMINA NOBEL BIOCARE AB
K053068 11/01/2005 PROCERA BRIDGE LAMINATE, MODEL 40-4002 NOBEL BIOCARE AB
K053091 11/03/2005 PROCERA IMPLANT BRIDGE ZIRCONIA NOBEL BIOCARE AB
K053125 11/07/2005 PROCERA BRIDGE ZIRCONIA NOBEL BIOCARE AB
K120954 03/30/2012 NOBELPROCERA PEEK ABUTMENTS NOBEL BIOCARE AB
K081128 04/21/2008 MOLAR IMPLANT NOBEL BIOCARE AB


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