FDA 510(k) Applications Submitted by IVOCLAR VIVADENT, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K020183 |
01/18/2002 |
PISCES PLUS (DW286 C) |
IVOCLAR VIVADENT, INC. |
| K020253 |
01/24/2002 |
4 ALL (DW286A) |
IVOCLAR VIVADENT, INC. |
| K020898 |
01/24/2002 |
D.SIGN 15 (DW286 B) |
IVOCLAR VIVADENT, INC. |
| K030435 |
02/10/2003 |
BIOUNIVERSAL PKF |
IVOCLAR VIVADENT, INC. |
| K030436 |
02/10/2003 |
BIO UNIVERSAL |
IVOCLAR VIVADENT, INC. |
| K041433 |
05/28/2004 |
BRIGHT GOLD XH |
IVOCLAR VIVADENT, INC. |
| K021892 |
06/07/2002 |
BRIGHT GOLD |
IVOCLAR VIVADENT, INC. |
| K022811 |
08/23/2002 |
W-5 |
IVOCLAR VIVADENT, INC. |
| K032715 |
09/02/2003 |
DW 296 #15 SOLDER |
IVOCLAR VIVADENT, INC. |
| K022969 |
09/06/2002 |
UNIVERSAL CERAMIC SOLDER |
IVOCLAR VIVADENT, INC. |
| K013809 |
11/15/2001 |
D.SIGN 59 |
IVOCLAR VIVADENT, INC. |
| K032493 |
08/12/2003 |
ALEXANDER |
IVOCLAR VIVADENT, INC. |
| K062713 |
09/11/2006 |
ADHESIVE DC ACTIVATOR |
IVOCLAR VIVADENT, INC. |
| K014042 |
12/07/2001 |
D.SIGN 84 |
IVOCLAR VIVADENT, INC. |
| K050453 |
02/22/2005 |
ODYSSEY 2.4G, DENLASER ELITE, MODEL 002-00050 |
IVOCLAR VIVADENT, INC. |
| K042819 |
10/12/2004 |
TETRIC EVOCERAM |
IVOCLAR VIVADENT, INC. |
| K042820 |
10/12/2004 |
SYSTEMP.C&B PLUS |
IVOCLAR VIVADENT, INC. |
| K103391 |
11/19/2010 |
IVOBASE HYBRID, IVOBASE HIGH IMPACT |
IVOCLAR VIVADENT, INC. |
| K103528 |
11/30/2010 |
IPS EMPRESS DIRECT FLOW |
IVOCLAR VIVADENT, INC. |
| K093708 |
12/02/2009 |
TELIO CAD |
IVOCLAR VIVADENT, INC. |
| 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. |
| 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. |
| K051782 |
07/01/2005 |
BLUEPHASE 16I |
IVOCLAR VIVADENT, INC. |
| K071848 |
07/05/2007 |
IPS INLINE POM SYSTEM |
IVOCLAR VIVADENT, INC. |
| K032470 |
08/11/2003 |
MULTILINK |
IVOCLAR VIVADENT, INC. |
| K042847 |
10/15/2004 |
SYSTEMP.CEM |
IVOCLAR VIVADENT, INC. |
| K042848 |
10/15/2004 |
FRC POSTEC PLUS |
IVOCLAR VIVADENT, INC. |
| K042846 |
10/15/2004 |
SYSTEMP.LINK |
IVOCLAR VIVADENT, INC. |
| 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. |
| K013929 |
11/28/2001 |
HELIOMOLAR HB TRANSLUCENT SHADES |
IVOCLAR VIVADENT, INC. |
| K014082 |
12/11/2001 |
D.SIGN 53, MODEL NA1012204 |
IVOCLAR VIVADENT, INC. |
| 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. |
| K051705 |
06/24/2005 |
IPS E.MAX CAD/IPS E.MAX ZIRCAD |
IVOCLAR VIVADENT, INC. |
| K061781 |
06/26/2006 |
MULTILINK SPRINT |
IVOCLAR VIVADENT, 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. |
| K023035 |
09/12/2002 |
SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER |
IVOCLAR VIVADENT, 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. |
| K093744 |
12/04/2009 |
EXCITE F AND EXCITE DSC |
IVOCLAR VIVADENT, INC. |
| K024094 |
12/11/2002 |
4 SEASONS |
IVOCLAR VIVADENT, INC. |
| K143575 |
12/17/2014 |
Accu-Dent XD Tray, Accu-Dent XD Syringe |
IVOCLAR VIVADENT, INC. |
| K153753 |
12/29/2015 |
TelioCAD Multi |
IVOCLAR VIVADENT, INC. |
|
|
