Medical Device Manufacturer · US , South Bend , IN

Heraeus Kulzer, LLC - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 2009

Recent clearances: XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML, IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF, FLEXITIME FAST & SCAN LIGHT FLOW

View 11 510(k) Devices ↓

11

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - Heraeus Kulzer, LLC Dental ✕

11 devices

1-11 of 11

Cleared May 17, 2013

XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML

Cleared Dec 07, 2012

IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND...

Cleared Jul 25, 2012

FLEXITIME FAST & SCAN LIGHT FLOW

Cleared Jul 13, 2012

FLEXITIME MONOPHASE PRO SCAN

Cleared Dec 14, 2011

VENUS PEARL PLT REFILL A1

Cleared Sep 29, 2011

PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID

Cleared Apr 29, 2011

PALAXPRESS ULTRA POWDER (PINK)

Cleared Dec 21, 2010

FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST &...

Cleared Sep 07, 2010

FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY...

Cleared Mar 05, 2010

GLUMA DESENSITIZER POWER GEL

Cleared Sep 03, 2009

VENUS DIAMOND FLOW