Medical Device Manufacturer · US , Hanover , MA

Denali Corporation - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2007

Recent clearances: Calcium Bridge, Triumph Resin Dam, Resolve 2.0

View 9 510(k) Devices ↓

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Denali Corporation Dental ✕

9 devices

1-9 of 9

Cleared Feb 26, 2016

Cleared Feb 18, 2016

Triumph Resin Dam

Cleared Dec 16, 2015

Cleared Nov 10, 2014

DENALI 501CEMENT

Cleared Mar 14, 2014

CERCOM II CEMENT

Cleared Jan 17, 2008

AURAVENEER CEMENT

Cleared Jun 05, 2007

AURALAY PIT & FISSURE SEALANT

Cleared May 10, 2007

FUSION RESIN CEMENT AND CORE KIT

Cleared May 09, 2007

AURAVUE PIT & FISSURE SEALANT