FDA 510(k) Applications Submitted by DONNA MARIE HARTNETT
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K132209 |
07/16/2013 |
IPS E.MAX CAD ABUTMENT SOLUTIONS |
IVOCLAR VIVADENT AG |
| K042820 |
10/12/2004 |
SYSTEMP.C&B PLUS |
IVOCLAR VIVADENT, INC. |
| K042819 |
10/12/2004 |
TETRIC EVOCERAM |
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 |
| K090704 |
03/17/2009 |
MULTILINK IMPLANT |
IVOCLAR VIVADENT, INC. |
| K090701 |
03/17/2009 |
EMPRESS DIRECT |
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. |
| K042848 |
10/15/2004 |
FRC POSTEC PLUS |
IVOCLAR VIVADENT, INC. |
| K042846 |
10/15/2004 |
SYSTEMP.LINK |
IVOCLAR VIVADENT, INC. |
| K042847 |
10/15/2004 |
SYSTEMP.CEM |
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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