Medical Device Manufacturer · US , Elkhart , IN

Heraeus Kulzer, Inc.

145 submissions · 145 cleared · Since 1988
145
Total
145
Cleared
0
Denied

Heraeus Kulzer, Inc. — FDA 510(k) Submissions

Heraeus Kulzer, Inc. has submitted 145 FDA 510(k) premarket notifications since 1988, of which 145 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Agent, Tooth Bonding, Resin, Material, Impression, Material, Tooth Shade, Resin, Resin, Denture, Relining, Repairing, Rebasing, Glucose Oxidase, Glucose . Use the specialty filter in the sidebar to narrow results.

145 devices
1–25 of 145
FLEXITIME FLOW
K091494 · ELW Material, Impression · Dental
Jul 2009 72d
HKBOND 2006
K063062 · KLE Agent, Tooth Bonding, Resin · Dental
Dec 2006 57d
MONDIAL
K060994 · ELM Denture, Plastic, Teeth · Dental
May 2006 41d
HERACERAM ZIRKONIA
K052543 · EIH Powder, Porcelain · Dental
Oct 2005 40d
PALAIMPACT
K043504 · EBI Resin, Denture, Relining,... · Dental
Jan 2005 39d
VERSYO.DIRECT
K043295 · EBI Resin, Denture, Relining,... · Dental
Jan 2005 37d
FLEXITIME XTREME
K042878 · ELW Material, Impression · Dental
Dec 2004 60d
OSTIM
K030052 · LYC Bone Grafting Material,... · Dental
Dec 2004 700d
HERACERAM PRESS
K040859 · EIH Powder, Porcelain · Dental
May 2004 48d
NDX-40 ALLOY
K040043 · EJT Alloy, Gold-based Noble... · Dental
Mar 2004 51d
ARTIC
K033628 · ELM Denture, Plastic, Teeth · Dental
Jan 2004 58d
VENUS FLOW
K033665 · EBF Material, Tooth Shade, Resin · Dental
Dec 2003 39d
VERSYO.BOND
K033629 · EBI Resin, Denture, Relining,... · Dental
Dec 2003 33d
P2 POLYETHER
K030318 · ELW Material, Impression · Dental
Apr 2003 63d
IBOND GLUMA INSIDE
K022612 · KLE Agent, Tooth Bonding, Resin · Dental
Oct 2002 83d
VENUS UNIVERSAL LIGHT CURING COMPOSITE
K020131 · EBF Material, Tooth Shade, Resin · Dental
Feb 2002 44d
TRANSLUX ENERGY
K012341 · EBZ Activator, Ultraviolet,... · Dental
Aug 2001 37d
PREVISION CHEM
K010541 · EMA Cement, Dental · Dental
Jul 2001 158d
PREMIUM
K011130 · ELM Denture, Plastic, Teeth · Dental
Jul 2001 83d
VERSYO.COM
K010800 · EBI Resin, Denture, Relining,... · Dental
May 2001 76d
RD-3008
K011036 · EJT Alloy, Gold-based Noble... · Dental
May 2001 35d
FLEXTIME MAGNUM 360
K003930 · ELW Material, Impression · Dental
Feb 2001 43d
FLEXTIME
K000629 · ELW Material, Impression · Dental
Apr 2000 41d
SOLITAIRE 2
K993932 · EBF Material, Tooth Shade, Resin · Dental
Dec 1999 34d
PRE-VISION FILL
K993602 · EBF Material, Tooth Shade, Resin · Dental
Dec 1999 51d

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