FDA 510(k) Applications Submitted by HERAEUS KULZER, LLC
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K110037 |
01/06/2011 |
PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID |
HERAEUS KULZER, LLC |
| 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 |
| K093575 |
11/18/2009 |
GLUMA DESENSITIZER POWER GEL |
HERAEUS KULZER, LLC |
| K113574 |
12/02/2011 |
FLEXITIME MONOPHASE PRO SCAN |
HERAEUS KULZER, LLC |
| K130647 |
03/11/2013 |
XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50ML |
HERAEUS KULZER, LLC |
| K120914 |
03/27/2012 |
FLEXITIME FAST & SCAN LIGHT FLOW |
HERAEUS KULZER, LLC |
| K123278 |
10/22/2012 |
IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF |
HERAEUS KULZER, LLC |
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