FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

146 results for "Heraeus Kulzer, Inc."
1–24 of 146
Search insights Median review: 75d Cleared: 100% Top manufacturer: Heraeus Kulzer, Inc. Lead specialty: Dental
Cleared Jul 31, 2009
FLEXITIME FLOW
K091494 · ELW
Heraeus Kulzer, Inc.
Dental · 72d
Cleared Dec 05, 2008
FLEXITIME BITE
K082591 · ELW
Heraeus Kulzer, Inc., Dental Products...
Dental · 88d
Cleared Dec 01, 2006
HKBOND 2006
K063062 · KLE
Heraeus Kulzer, Inc.
Dental · 57d
Cleared May 22, 2006
MONDIAL
K060994 · ELM
Heraeus Kulzer, Inc.
Dental · 41d
Cleared Oct 25, 2005
HERACERAM ZIRKONIA
K052543 · EIH
Heraeus Kulzer, Inc.
Dental · 40d
Cleared Jan 28, 2005
PALAIMPACT
K043504 · EBI
Heraeus Kulzer, Inc.
Dental · 39d
Cleared Jan 05, 2005
VERSYO.DIRECT
K043295 · EBI
Heraeus Kulzer, Inc.
Dental · 37d
Cleared Dec 17, 2004
FLEXITIME XTREME
K042878 · ELW
Heraeus Kulzer, Inc.
Dental · 60d
Cleared Dec 06, 2004
OSTIM
K030052 · LYC
Heraeus Kulzer, Inc.
Dental · 700d
Cleared May 20, 2004
HERACERAM PRESS
K040859 · EIH
Heraeus Kulzer, Inc.
Dental · 48d
Cleared Mar 03, 2004
NDX-40 ALLOY
K040043 · EJT
Heraeus Kulzer, Inc.
Dental · 51d
Cleared Jan 16, 2004
ARTIC
K033628 · ELM
Heraeus Kulzer, Inc.
Dental · 58d
Cleared Dec 30, 2003
VENUS FLOW
K033665 · EBF
Heraeus Kulzer, Inc.
Dental · 39d
Cleared Dec 22, 2003
VERSYO.BOND
K033629 · EBI
Heraeus Kulzer, Inc.
Dental · 33d
Cleared Apr 03, 2003
P2 POLYETHER
K030318 · ELW
Heraeus Kulzer, Inc.
Dental · 63d
Cleared Oct 28, 2002
IBOND GLUMA INSIDE
K022612 · KLE
Heraeus Kulzer, Inc.
Dental · 83d
Cleared Feb 28, 2002
VENUS UNIVERSAL LIGHT CURING COMPOSITE
K020131 · EBF
Heraeus Kulzer, Inc.
Dental · 44d
Cleared Aug 30, 2001
TRANSLUX ENERGY
K012341 · EBZ
Heraeus Kulzer, Inc.
Dental · 37d
Cleared Jul 31, 2001
PREVISION CHEM
K010541 · EMA
Heraeus Kulzer, Inc.
Dental · 158d
Cleared Jul 05, 2001
PREMIUM
K011130 · ELM
Heraeus Kulzer, Inc.
Dental · 83d
Cleared May 31, 2001
VERSYO.COM
K010800 · EBI
Heraeus Kulzer, Inc.
Dental · 76d
Cleared May 10, 2001
RD-3008
K011036 · EJT
Heraeus Kulzer, Inc.
Dental · 35d
Cleared Feb 01, 2001
FLEXTIME MAGNUM 360
K003930 · ELW
Heraeus Kulzer, Inc.
Dental · 43d
Cleared Apr 05, 2000
FLEXTIME
K000629 · ELW
Heraeus Kulzer, Inc.
Dental · 41d