Medical Device Manufacturer · DE , Seefeld

Espe GmbH & Co. Kg. - FDA 510(k) Cleared Devices

17 submissions · 17 cleared · Since 1995

Recent clearances: POSITION PENTA, POSITION PENTA QUICK, SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINFONY MAGIC MODIFIERS, SINFONY OPAQUER, KETAC-FIL APLICAP PLUS

17

Total

17

Cleared

0

Denied

FDA 510(k) Regulatory Record - Espe GmbH & Co. Kg. Dental ✕

17 devices

1-12 of 17

Cleared Jan 29, 1998

POSITION PENTA, POSITION PENTA QUICK

Cleared Dec 22, 1997

SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT...

Cleared Nov 17, 1997

KETAC-FIL APLICAP PLUS

Cleared Oct 02, 1997

Cleared Nov 27, 1996

Cleared Nov 15, 1996

Cleared Sep 12, 1996

EBS (ESPE BONDING SYSTEM)

Cleared Sep 11, 1996

PERTAC II/PERTAC II APLITIP

Cleared Sep 11, 1996

HYTAC APLITIP/HYTAC OSB

Cleared May 16, 1996

KETAC-MOLAR APLICAP

Cleared Mar 15, 1996

DIMENSION PENTA/DIMENSION GARANT L/POLYVINYL SILOXANE ADHESIVE

Cleared Dec 01, 1995