Medical Device Manufacturer · US , South Bend , IN

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

10 submissions · 10 cleared · Since 2004

10

Total

10

Cleared

0

Denied

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

7 devices

1-7 of 7

Cleared Jan 21, 2009

IBOND TOTAL ETCH

Cleared Apr 21, 2008

CUTTERSIL ACTIVATOR UNIVERSAL PLUS

Cleared Feb 04, 2008

Cleared Nov 22, 2006

RETENTION FLOW OPAQUE

Cleared Jun 07, 2005

IBOND NEXT GENERATION

Cleared Sep 08, 2004

TRANSLUX POWER BLUE

Cleared Mar 01, 2004

HERADOR EC, PF, C, H, NH, G, GG AND MP