Heraeus Kulzer, LLC.
FDA Regulatory Profile
Heraeus Kulzer, LLC. appears in FDA public data with 2 recalls, 166 510(k) clearances, 1 FDA inspection, and 1 compliance action on record. Its most recent recall (Z-1651-2014, Class II) was initiated on April 23, 2014. Its most recent 510(k) clearance was granted on May 17, 2013.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 166
- Inspections
- 1
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1651-2014 | Class II | Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device. For reduct | April 23, 2014 |
| Z-1133-2014 | Class II | BencoDental tartar & stain remover ultrasonic cleaning solution Product Usage: Formulated especi | February 10, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K130647 | XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50ML | May 17, 2013 |
| K123278 | IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE AS | December 7, 2012 |
| K120914 | FLEXITIME FAST & SCAN LIGHT FLOW | July 25, 2012 |
| K113574 | FLEXITIME MONOPHASE PRO SCAN | July 13, 2012 |
| K112501 | VENUS PEARL PLT REFILL A1 | December 14, 2011 |
| K111832 | PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID | September 29, 2011 |
| K110037 | PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID | April 29, 2011 |
| K102770 | FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW | December 21, 2010 |
| K101617 | FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILL | September 7, 2010 |
| K093575 | GLUMA DESENSITIZER POWER GEL | March 5, 2010 |
| K091635 | VENUS DIAMOND FLOW | September 3, 2009 |
| K091494 | FLEXITIME FLOW | July 31, 2009 |
| K083652 | IBOND TOTAL ETCH | January 21, 2009 |
| K080338 | CUTTERSIL ACTIVATOR UNIVERSAL PLUS | April 21, 2008 |
| K073554 | NEUN | February 4, 2008 |
| K063062 | HKBOND 2006 | December 1, 2006 |
| K062515 | RETENTION FLOW OPAQUE | November 22, 2006 |
| K060994 | MONDIAL | May 22, 2006 |
| K052543 | HERACERAM ZIRKONIA | October 25, 2005 |
| K050085 | OSTEOPAL V | September 14, 2005 |