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Heraeus Kulzer, LLC.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
166
Inspections
1
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1651-2014Class IIGluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device. For reductApril 23, 2014
Z-1133-2014Class IIBencoDental tartar & stain remover ultrasonic cleaning solution Product Usage: Formulated especiFebruary 10, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K130647XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50MLMay 17, 2013
K123278IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASDecember 7, 2012
K120914FLEXITIME FAST & SCAN LIGHT FLOWJuly 25, 2012
K113574FLEXITIME MONOPHASE PRO SCANJuly 13, 2012
K112501VENUS PEARL PLT REFILL A1December 14, 2011
K111832PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUIDSeptember 29, 2011
K110037PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUIDApril 29, 2011
K102770FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOWDecember 21, 2010
K101617FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILLSeptember 7, 2010
K093575GLUMA DESENSITIZER POWER GELMarch 5, 2010
K091635VENUS DIAMOND FLOWSeptember 3, 2009
K091494FLEXITIME FLOWJuly 31, 2009
K083652IBOND TOTAL ETCHJanuary 21, 2009
K080338CUTTERSIL ACTIVATOR UNIVERSAL PLUSApril 21, 2008
K073554NEUNFebruary 4, 2008
K063062HKBOND 2006December 1, 2006
K062515RETENTION FLOW OPAQUENovember 22, 2006
K060994MONDIALMay 22, 2006
K052543HERACERAM ZIRKONIAOctober 25, 2005
K050085OSTEOPAL VSeptember 14, 2005