ClearanceBrief
Company ยท US

Heraeus Kulzer, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 2013. Name variants (Inc, Corp, punctuation) are merged.

170510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
4recalls that name a 510(k)

Product codes

CodeDeviceRecords
ELWMaterial, Impression25
KLEAgent, Tooth Bonding, Resin19
EBFMaterial, Tooth Shade, Resin18
EBIResin, Denture, Relining, Repairing, Rebasing13
CGAGlucose Oxidase, Glucose10
LODBone Cement7
CFRHexokinase, Glucose6
LCPAssay, Glycosylated Hemoglobin4
EJTAlloy, Gold-Based Noble Metal3
ELMDenture, Plastic, Teeth3
GKZCounter, Differential Cell3
CITNadh Oxidation/Nad Reduction, Ast/Sgot2
CKANadh Oxidation/Nad Reduction, Alt/Sgpt2
EBGCrown And Bridge, Temporary, Resin2
EBHMaterial, Impression Tray, Resin2
EBZActivator, Ultraviolet, For Polymerization2
EGDWax, Dental, Intraoral2
EIHPowder, Porcelain2
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use2
JJQColorimeter, Photometer, Spectrophotometer For Clinical Use2

Latest 510(k) clearances

Decided510(k)Device and applicantCode
May 17, 2013K130647XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50ML
Heraeus Kulzer, LLC
ELW
Dec 7, 2012K123278IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF
Heraeus Kulzer, LLC
KLE
Jul 25, 2012K120914FLEXITIME FAST & SCAN LIGHT FLOW
Heraeus Kulzer, LLC
ELW
Jul 13, 2012K113574FLEXITIME MONOPHASE PRO SCAN
Heraeus Kulzer, LLC
ELW
Dec 14, 2011K112501VENUS PEARL PLT REFILL A1
Heraeus Kulzer, LLC
EBF
Sep 29, 2011K111832PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID
Heraeus Kulzer, LLC
EBI
Apr 29, 2011K110037PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID
Heraeus Kulzer, LLC
EBI
Dec 21, 2010K102770FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW
Heraeus Kulzer, LLC
ELW
Sep 7, 2010K101617FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILL
Heraeus Kulzer, LLC
ELW
Mar 5, 2010K093575GLUMA DESENSITIZER POWER GEL
Heraeus Kulzer, LLC
LBH
Sep 3, 2009K091635VENUS DIAMOND FLOW
Heraeus Kulzer, LLC
EBF
Jul 31, 2009K091494FLEXITIME FLOW
Heraeus Kulzer, Inc.
ELW
Jan 21, 2009K083652IBOND TOTAL ETCH
Heraeus Kulzer,GmbH
KLE
Apr 21, 2008K080338CUTTERSIL ACTIVATOR UNIVERSAL PLUS
Heraeus Kulzer,GmbH
ELW
Feb 4, 2008K073554NEUN
Heraeus Kulzer,GmbH
EBF
Dec 1, 2006K063062HKBOND 2006
Heraeus Kulzer, Inc.
KLE
Nov 22, 2006K062515RETENTION FLOW OPAQUE
Heraeus Kulzer,GmbH
EBF
May 22, 2006K060994MONDIAL
Heraeus Kulzer, Inc.
ELM
Oct 25, 2005K052543HERACERAM ZIRKONIA
Heraeus Kulzer, Inc.
EIH
Sep 14, 2005K050085OSTEOPAL V
Heraeus Kulzer,GmbH, DE
LOD
Jul 7, 2005K050855PALAMED G
Heraeus Kulzer,GmbH, DE
LOD
Jul 7, 2005K050854PALACOS LV+G
Heraeus Kulzer,GmbH, DE
LOD
Jun 7, 2005K051006IBOND NEXT GENERATION
Heraeus Kulzer,GmbH
KLE
Jan 28, 2005K043504PALAIMPACT
Heraeus Kulzer, Inc.
EBI
Jan 5, 2005K043295VERSYO.DIRECT
Heraeus Kulzer, Inc.
EBI
Dec 17, 2004K042878FLEXITIME XTREME
Heraeus Kulzer, Inc.
ELW
Dec 6, 2004K030052OSTIM
Heraeus Kulzer, Inc.
LYC
Sep 8, 2004K042199TRANSLUX POWER BLUE
Heraeus Kulzer,GmbH
EBZ
May 25, 2004K031673REFOBACIN -PALACOS G
Heraeus Kulzer GmbH & Co. KG, DE
LOD
May 20, 2004K040859HERACERAM PRESS
Heraeus Kulzer, Inc.
EIH
Mar 3, 2004K040043NDX-40 ALLOY
Heraeus Kulzer, Inc.
EJT
Mar 1, 2004K034049HERADOR 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
EJT
Jan 16, 2004K033628ARTIC
Heraeus Kulzer, Inc.
ELM
Dec 30, 2003K033665VENUS FLOW
Heraeus Kulzer, Inc.
EBF
Dec 22, 2003K033629VERSYO.BOND
Heraeus Kulzer, Inc.
EBI
Sep 23, 2003K030903OSTEOPAL
Heraeus Kulzer GmbH & Co. KG, DE
LOD
Sep 23, 2003K030902PALACOS R
Heraeus Kulzer GmbH & Co. KG, DE
LOD
Apr 3, 2003K030318P2 POLYETHER
Heraeus Kulzer, Inc.
ELW
Feb 26, 2003K022251PALABOND
Heraeus Kulzer GmbH & Co. KG, DE
LOD
Oct 28, 2002K022612IBOND GLUMA INSIDE
Heraeus Kulzer, Inc.
KLE
Feb 28, 2002K020131VENUS UNIVERSAL LIGHT CURING COMPOSITE
Heraeus Kulzer, Inc.
EBF
Aug 30, 2001K012341TRANSLUX ENERGY
Heraeus Kulzer, Inc.
EBZ
Jul 31, 2001K010541PREVISION CHEM
Heraeus Kulzer, Inc.
EMA
Jul 5, 2001K011130PREMIUM
Heraeus Kulzer, Inc.
ELM
May 31, 2001K010800VERSYO.COM
Heraeus Kulzer, Inc.
EBI
May 10, 2001K011036RD-3008
Heraeus Kulzer, Inc.
EJT
Feb 1, 2001K003930FLEXTIME MAGNUM 360
Heraeus Kulzer, Inc.
ELW
Apr 5, 2000K000629FLEXTIME
Heraeus Kulzer, Inc.
ELW
Dec 22, 1999K993932SOLITAIRE 2
Heraeus Kulzer, Inc.
EBF
Dec 15, 1999K993602PRE-VISION FILL
Heraeus Kulzer, Inc.
EBF

Newest 50 of 170.

Latest recalls

DateFirm and productCodeLinked 510(k)
May 23, 2014Heraeus Kulzer, LLC.
Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device. For reduction or elimination of pain in exposed cervical areas that do not require restoration. It is also used f
Terminated		 LBHNone listed
Mar 4, 2014Heraeus Kulzer, LLC.
BencoDental tartar & stain remover ultrasonic cleaning solution Product Usage: Formulated especially for removal of calculus, tartar, tobacco and food stains from dentures, bridges, orthodontic appl
Terminated		 KZPNone listed
Mar 15, 2005Heraeus Kulzer Inc.
Heraeus Kulzer brand P2 Magnum 360 Trial Kit Monophase; catalog number 66009582.
Terminated		 ELWK030318
Mar 15, 2005Heraeus Kulzer Inc.
Heraeus Kulzer brand P2 Magnum 360 Monophase 3X (2x360); catalog number 66009584.
Terminated		 ELWK030318
Mar 15, 2005Heraeus Kulzer Inc.
Heraeus Kulzer brand P2 Magnum 360 Trial Kit, Heavy + Light; catalog number 66009583.
Terminated		 ELWK030318
Mar 15, 2005Heraeus Kulzer Inc.
Heraeus Kulzer brand P2 Magnum 360 Heavy 3X (2x360); catalog number 66009585.
Terminated		 ELWK030318
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