FDA 510(k) Applications Submitted by CHERYL V ZIMMERMAN
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K110037 |
01/06/2011 |
PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID |
HERAEUS KULZER, LLC |
| K091494 |
05/20/2009 |
FLEXITIME FLOW |
HERAEUS KULZER, INC. |
| K091635 |
06/04/2009 |
VENUS DIAMOND FLOW |
HERAEUS KULZER, LLC |
| K101617 |
06/09/2010 |
FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILL |
HERAEUS KULZER, LLC |
| K111832 |
06/28/2011 |
PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID |
HERAEUS KULZER, LLC |
| K112501 |
08/30/2011 |
VENUS PEARL PLT REFILL A1 |
HERAEUS KULZER, LLC |
| K102770 |
09/24/2010 |
FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW |
HERAEUS KULZER, LLC |
| K964038 |
10/04/1996 |
CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG |
HERAEUS KULZER, INC. |
| K083652 |
12/09/2008 |
IBOND TOTAL ETCH |
HERAEUS KULZER GMBH |
| K003930 |
12/20/2000 |
FLEXTIME MAGNUM 360 |
HERAEUS KULZER, INC. |
| K030052 |
01/06/2003 |
OSTIM |
HERAEUS KULZER, INC. |
| K040043 |
01/12/2004 |
NDX-40 ALLOY |
HERAEUS KULZER, INC. |
| K020131 |
01/15/2002 |
VENUS UNIVERSAL LIGHT CURING COMPOSITE |
HERAEUS KULZER, INC. |
| K990143 |
01/19/1999 |
GLUMA ONE BOND |
HERAEUS KULZER, INC. |
| K030318 |
01/30/2003 |
P2 POLYETHER |
HERAEUS KULZER, INC. |
| K080338 |
02/07/2008 |
CUTTERSIL ACTIVATOR UNIVERSAL PLUS |
HERAEUS KULZER GMBH |
| K010541 |
02/23/2001 |
PREVISION CHEM |
HERAEUS KULZER, INC. |
| K000629 |
02/24/2000 |
FLEXTIME |
HERAEUS KULZER, INC. |
| K990756 |
03/08/1999 |
FLOW LINE |
HERAEUS KULZER, INC. |
| K971155 |
03/28/1997 |
MEMOREG |
HERAEUS KULZER, INC. |
| K040859 |
04/02/2004 |
HERACERAM PRESS |
HERAEUS KULZER, INC. |
| K060994 |
04/11/2006 |
MONDIAL |
HERAEUS KULZER, INC. |
| K051006 |
04/20/2005 |
IBOND NEXT GENERATION |
HERAEUS KULZER GMBH |
| K991425 |
04/23/1999 |
XANTOPREN COMFORT |
HERAEUS KULZER, INC. |
| K981546 |
04/30/1998 |
NTI CLENCHING SUPPRESSION SYSTEM |
HERAEUS KULZER, INC. |
| K972101 |
06/04/1997 |
SOLITAIRE |
HERAEUS KULZER, INC. |
| K992292 |
07/07/1999 |
GLUMA COMFORT BOND + DESENSITIZER |
HERAEUS KULZER, INC. |
| K012341 |
07/24/2001 |
TRANSLUX ENERGY |
HERAEUS KULZER, INC. |
| K022612 |
08/06/2002 |
IBOND GLUMA INSIDE |
HERAEUS KULZER, INC. |
| K042199 |
08/13/2004 |
TRANSLUX POWER BLUE |
HERAEUS KULZER GMBH |
| K062515 |
08/28/2006 |
RETENTION FLOW OPAQUE |
HERAEUS KULZER GMBH |
| K992985 |
09/03/1999 |
GLUMA COMFORT BOND |
HERAEUS KULZER, INC. |
| K082591 |
09/08/2008 |
FLEXITIME BITE |
HERAEUS KULZER, INC., DENTAL PRODUCTS DIVISION |
| K052543 |
09/15/2005 |
HERACERAM ZIRKONIA |
HERAEUS KULZER, INC. |
| K973694 |
09/26/1997 |
PROVIL NOVO |
HERAEUS KULZER, INC. |
| K063062 |
10/05/2006 |
HKBOND 2006 |
HERAEUS KULZER, INC. |
| K964140 |
10/15/1996 |
GLUMA CONDITIONER |
HERAEUS KULZER, INC. |
| K042878 |
10/18/2004 |
FLEXITIME XTREME |
HERAEUS KULZER, INC. |
| K993602 |
10/25/1999 |
PRE-VISION FILL |
HERAEUS KULZER, INC. |
| K993932 |
11/18/1999 |
SOLITAIRE 2 |
HERAEUS KULZER, INC. |
| K093575 |
11/18/2009 |
GLUMA DESENSITIZER POWER GEL |
HERAEUS KULZER, LLC |
| K033629 |
11/19/2003 |
VERSYO.BOND |
HERAEUS KULZER, INC. |
| K033628 |
11/19/2003 |
ARTIC |
HERAEUS KULZER, INC. |
| K974390 |
11/21/1997 |
GLUMA ONE BOND |
HERAEUS KULZER, INC. |
| K033665 |
11/21/2003 |
VENUS FLOW |
HERAEUS KULZER, INC. |
| K043295 |
11/29/2004 |
VERSYO.DIRECT |
HERAEUS KULZER, INC. |
| K073554 |
12/18/2007 |
NEUN |
HERAEUS KULZER GMBH |
| K043504 |
12/20/2004 |
PALAIMPACT |
HERAEUS KULZER, INC. |
| K965163 |
12/24/1996 |
CUTTERSIL COMFORT |
HERAEUS KULZER, INC. |
| K965165 |
12/24/1996 |
CUTTERSIL COMFORT HARDENER |
HERAEUS KULZER, INC. |
| K034049 |
12/30/2003 |
HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM |
HERAEUS KULZER GMBH |
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