Heraeus Kulzer, LLC is one of 5675 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Heraeus Kulzer, LLC - FDA 510(k) Cleared Devices
11
Total
11
Cleared
0
Denied
Heraeus Kulzer, LLC has 11 FDA 510(k) cleared dental devices. Based in South Bend, US.
Historical record: 11 cleared submissions from 2009 to 2013.
Browse the complete list of FDA 510(k) cleared dental devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Heraeus Kulzer, LLC
11 devices
Cleared
May 17, 2013
XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML
Dental
67d
Cleared
Dec 07, 2012
IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND...
Dental
46d
Cleared
Jul 25, 2012
FLEXITIME FAST & SCAN LIGHT FLOW
Dental
120d
Cleared
Jul 13, 2012
FLEXITIME MONOPHASE PRO SCAN
Dental
224d
Cleared
Dec 14, 2011
VENUS PEARL PLT REFILL A1
Dental
106d
Cleared
Sep 29, 2011
PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID
Dental
93d
Cleared
Apr 29, 2011
PALAXPRESS ULTRA POWDER (PINK)
Dental
113d
Cleared
Dec 21, 2010
FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST &...
Dental
88d
Cleared
Sep 07, 2010
FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY...
Dental
90d
Cleared
Mar 05, 2010
GLUMA DESENSITIZER POWER GEL
Dental
107d
Cleared
Sep 03, 2009
VENUS DIAMOND FLOW
Dental
91d