FDA 510(k) Applications Submitted by DON W HART

FDA 510(k) Number Submission Date Device Name Applicant
K940353 01/25/1994 BECKMAN BETA-2-MICROGLOBULIN (B2M) BECKMAN INSTRUMENTS, INC.
K951293 03/22/1995 QUANTITATE ENZYME VERIFIER SET BECKMAN INSTRUMENTS, INC.
K951635 04/07/1995 BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT, URINE APPLICATION, URINE PROTEIN CALIBRATOR, CONTROL BECKMAN INSTRUMENTS, INC.
K951964 04/27/1995 SYNCHRON ENZYME VALIDATOR SET BECKMAN INSTRUMENTS, INC.
K952180 05/09/1995 CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS BECKMAN INSTRUMENTS, INC.
K952427 05/24/1995 CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE PHOSPHOKINASE-N-ACETYL-L-CYSTEINE BECKMAN INSTRUMENTS, INC.
K952568 06/05/1995 BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT BECKMAN INSTRUMENTS, INC.
K922844 06/12/1992 BECKMAN VALPROIC ACID REAGENT BECKMAN INSTRUMENTS, INC.
K953979 08/23/1995 APOLIPOPROTEIN CALIBRATOR (APO-CAL) BECKMAN INSTRUMENTS, INC.
K944453 09/12/1994 QUANTITATE URIC ACID VERIFIER SET BECKMAN INSTRUMENTS, INC.
K944454 09/12/1994 QUANITITATE GBCC VERIFIER SET BECKMAN INSTRUMENTS, INC.
K944455 09/12/1994 QUANTITATE ELECTROLYTE VERIFIER SET (SERUM RANGE) BECKMAN INSTRUMENTS, INC.
K944452 09/12/1994 QUANTITATE ELECTROLYTE VERIFIER SET (URINE RANGE) BECKMAN INSTRUMENTS, INC.
K935362 11/04/1993 P-AMYLASE CONTROL BECKMAN
K945522 11/10/1994 I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS BECKMAN-DIAGNOSTIC SYSTEMS GROUP
K926060 12/01/1992 SYNCHRON CX5CE CLINICAL ANALYZER BECKMAN INSTRUMENTS, INC.
K936184 12/27/1993 VIGIL PRX CHEMISTRY CONTROL BECKMAN-DIAGNOSTIC SYSTEMS GROUP
K951170 03/15/1995 VIGIL MULTICHEK CONTROLS BECKMAN INSTRUMENTS, INC.
K132209 07/16/2013 IPS E.MAX CAD ABUTMENT SOLUTIONS IVOCLAR VIVADENT AG
K042819 10/12/2004 TETRIC EVOCERAM IVOCLAR VIVADENT, INC.
K042820 10/12/2004 SYSTEMP.C&B PLUS IVOCLAR VIVADENT, INC.
K133318 10/28/2013 ADHESE UNIVERSAL IVOCLAR VIVADENT AG
K103391 11/19/2010 IVOBASE HYBRID, IVOBASE HIGH IMPACT IVOCLAR VIVADENT, INC.
K103528 11/30/2010 IPS EMPRESS DIRECT FLOW IVOCLAR VIVADENT, INC.
K051342 05/23/2005 MEDICAL INTERPOROUS BONYF AG
K093708 12/02/2009 TELIO CAD IVOCLAR VIVADENT, INC.
K120134 01/17/2012 IPS E.MAX PRESS MULTI IVOCLAR VIVADENT AG
K060365 02/13/2006 APEXCAL IVOCLAR VIVADENT, INC.
K060565 03/03/2006 CONDYLAFORM II NFC IVOCLAR VIVADENT, INC.
K070646 03/08/2007 ADHESE ONE IVOCLAR VIVADENT, INC.
K120736 03/09/2012 SR PHONARES II IVOCLAR VIVADENT AG
K090701 03/17/2009 EMPRESS DIRECT IVOCLAR VIVADENT, INC.
K090704 03/17/2009 MULTILINK IMPLANT IVOCLAR VIVADENT, INC.
K090826 03/26/2009 MONOBOND PLUS IVOCLAR VIVADENT, INC.
K060891 03/31/2006 VIRTUAL IVOCLAR VIVADENT, INC.
K131487 05/23/2013 FLUOR PROTECTOR S IVOCLAR VIVADENT AG
K061851 06/30/2006 ZIRKONZAHN ICE ZIRKONZAHN GMBH
K051782 07/01/2005 BLUEPHASE 16I IVOCLAR VIVADENT, INC.
K071848 07/05/2007 IPS INLINE POM SYSTEM IVOCLAR VIVADENT, INC.
K012174 07/12/2001 ERIS LAYERING MATERIALS IVOCLAR NORTH AMERICA, INC.
K132230 07/18/2013 ICE ZIRKON TRANSLUZENT ZIRKONZAHN SRL
K032470 08/11/2003 MULTILINK IVOCLAR VIVADENT, INC.
K042846 10/15/2004 SYSTEMP.LINK IVOCLAR VIVADENT, INC.
K042847 10/15/2004 SYSTEMP.CEM IVOCLAR VIVADENT, INC.
K042848 10/15/2004 FRC POSTEC PLUS IVOCLAR VIVADENT, INC.
K123304 10/24/2012 SR NEXCO PASTE LAYERING MATERIALS, SR NEXCO OPAQUER, SR NEXCO LINER-SR NEXCO CONNECT, SR NEXCO STAINS, SR NEXCO RETENTIO IVOCLAR VIVADENT AG
K013584 10/30/2001 EXCITE SELF ETCH IVOCLAR VIVADENT, INC.
K013802 11/15/2001 FRC POSTEC IVOCLAR VIVADENT, INC.
K103379 11/17/2010 TELIO CS INLAY & TELIO CS ONLAY IVOCLAR VIVADENT, INC.
K013869 11/21/2001 SR IVOCRON IVOCLAR VIVADENT, INC.
K123613 11/23/2012 SYNSPAR ADVANCED ARDENT INC
K013929 11/28/2001 HELIOMOLAR HB TRANSLUCENT SHADES IVOCLAR VIVADENT, INC.
K014082 12/11/2001 D.SIGN 53, MODEL NA1012204 IVOCLAR VIVADENT, INC.
K120053 01/06/2012 IPS E.MAX PRESS - ABUTMENT SOLUTIONS IVOCLAR VIVADENT AG
K120432 02/13/2012 TELIO CS CEM IMPLANT IVOCLAR VIVADENT AG
K130436 02/21/2013 MULTILINK HYBRID ABUTMENT CEMENT IVOCLAR VIVADENT AG
K110756 03/18/2011 BLUEPHASE STYLE IVOCLAR VIVADENT, INC.
K030922 03/24/2003 VIVASENS IVOCLAR VIVADENT, INC.
K040795 03/29/2004 MULTICORE HB; MULTICORE FLOW IVOCLAR VIVADENT, INC.
K090941 04/03/2009 ADHESE ONE F IVOCLAR VIVADENT, INC.
K091019 04/09/2009 SPEEDCEM IVOCLAR VIVADENT, INC.
K091020 04/09/2009 BLUEPHASE 20I IVOCLAR VIVADENT, INC.
K040951 04/12/2004 SR ADORO IVOCLAR VIVADENT, INC.
K121359 05/07/2012 IPS 99 ONE AND IPS 99 CERAM IVOCLAR VIVADENT AG
K011490 05/15/2001 MODIFICATION TO EXCITE IVOCLAR NORTH AMERICA, INC.
K131753 06/14/2013 MERIDIAN AB ARDENT
K051705 06/24/2005 IPS E.MAX CAD/IPS E.MAX ZIRCAD IVOCLAR VIVADENT, INC.
K061781 06/26/2006 MULTILINK SPRINT IVOCLAR VIVADENT, INC.
K101814 06/29/2010 DIRECT CROWN NATURAL 1 CANDULOR USA, INC.
K111958 07/11/2011 TETRIC EVOCERAM BULK FILL IVOCLAR VIVADENT, INC.
K062258 08/04/2006 GENESIS DIODE LASER IVOCLAR VIVADENT, INC.
K072338 08/20/2007 CERVITEC PLUS IVOCLAR VIVADENT, INC.
K052463 09/08/2005 PROMETAL HN86 PROMETAL TECHNOLOGIES
K023035 09/12/2002 SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER IVOCLAR VIVADENT, INC.
K122852 09/18/2012 PHYSIOSTAR NFC CANDULOR USA, INC.
K132984 09/24/2013 SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S IVOCLAR VIVADENT, INC.
K013275 10/01/2001 ASTRALIS 10, MODELS # 559588, 561859 IVOCLAR VIVADENT, INC.
K013277 10/02/2001 ASTRALIS 7, MODEL 557545 IVOCLAR VIVADENT, INC.
K093331 10/26/2009 SR PHONARES NHC IVOCLAR VIVADENT, INC.
K033520 11/07/2003 BLUEPHASE IVOCLAR VIVADENT, INC.
K103556 12/02/2010 IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE) IVOCLAR VIVADENT, INC.
K033773 12/03/2003 CONCEPT HP ADD-ON; CONCEPT HP ENAMEL IVOCLAR VIVADENT AG
K093744 12/04/2009 EXCITE F AND EXCITE DSC IVOCLAR VIVADENT, INC.
K024094 12/11/2002 4 SEASONS IVOCLAR VIVADENT, INC.
K124008 12/27/2012 IPS E. MAX PRESS ABUTMENT SOLUTIONS FOR NOBEL BIOCARE IVOCLAR VIVADENT, AGIN
K143575 12/17/2014 Accu-Dent XD Tray, Accu-Dent XD Syringe IVOCLAR VIVADENT, INC.
K153753 12/29/2015 TelioCAD Multi IVOCLAR VIVADENT, INC.


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