FDA 510(k) Applications Submitted by HERAEUS KULZER, INC.
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K962812 |
07/18/1996 |
GLUMA DESENSITIZER/GLUMA 3 PRIMER |
HERAEUS KULZER, INC. |
K091494 |
05/20/2009 |
FLEXITIME FLOW |
HERAEUS KULZER, INC. |
K964038 |
10/04/1996 |
CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG |
HERAEUS KULZER, INC. |
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. |
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. |
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. |
K992985 |
09/03/1999 |
GLUMA COMFORT BOND |
HERAEUS KULZER, INC. |
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. |
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. |
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. |
K010800 |
03/16/2001 |
VERSYO.COM |
HERAEUS KULZER, INC. |
K011036 |
04/05/2001 |
RD-3008 |
HERAEUS KULZER, INC. |
K011130 |
04/13/2001 |
PREMIUM |
HERAEUS KULZER, INC. |
K970848 |
03/07/1997 |
SILOC SYSTEM |
HERAEUS KULZER, INC. |
K971733 |
05/09/1997 |
2 BOND 2 |
HERAEUS KULZER, INC. |
K961995 |
05/21/1996 |
QUICKSPLINT |
HERAEUS KULZER, INC. |
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