Medical Device Manufacturer · US , Elkhart , IN

Heraeus Kulzer, Inc. - FDA 510(k) Cleared Devices

145 submissions · 145 cleared · Since 1988

145

Total

145

Cleared

0

Denied

74 devices

51-74 of 74

Cleared Aug 06, 1993

PALAVIT 55 AND DENTACOLOR CONNECTOR

Cleared Jul 08, 1993

Cleared Jul 08, 1993

CHARISMA -- MODIFIED

Cleared Jun 18, 1993

PALATRAY LC MINT

Cleared Nov 17, 1992

Cleared Nov 04, 1992

Cleared Sep 29, 1992

Cleared Sep 16, 1992

Cleared Jun 09, 1992

Cleared Mar 19, 1992

Cleared Mar 11, 1992

DENTACOLOR(R) CRE-ACTIVE

Cleared Feb 03, 1992

Cleared Jan 31, 1992

ADS-GEL AND INSULATING-GEL

Cleared Jan 21, 1992

SILICOATER SYSTEM

Cleared Jan 17, 1992

Cleared Oct 09, 1991

ACCELAR 20 ADVANCE RAPID CURE REPAIR MATERIAL

Cleared Oct 09, 1991

MODERN MATERIALS ORTHODONTIC RESIN

Cleared Oct 04, 1991

Cleared Jun 06, 1991

CUTTERSIL MUCOSA

Cleared Jun 06, 1991

Cleared Jun 06, 1991

PERFOURM PUTTY SOFT

Cleared Jun 06, 1991

CUTTERSIL FUNCTION ACTIVATOR

Cleared Jun 06, 1991

MELIODENT, DENTURE RESIN

Cleared Feb 01, 1990

MODIFIED GLUMA BONDING SYSTEM