Medical Device Manufacturer · US , Louisville , CO

Novocol, Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2004

Recent clearances: BULK FILL FLOWABLE COMPOSITE, BIOROOT RCS, BPA-FREE MICROHYBID COMPOSITE

View 9 510(k) Devices ↓

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Novocol, Inc. Dental ✕

9 devices

1-9 of 9

Cleared Nov 14, 2014

BULK FILL FLOWABLE COMPOSITE

Cleared Oct 17, 2013

Cleared Dec 11, 2012

BPA-FREE MICROHYBID COMPOSITE

Cleared Jul 31, 2012

DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT

Cleared May 21, 2012

ORTHODONTIC FLOWABLE BRACKET ADHESIVE

Cleared May 17, 2011

SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL

Cleared Nov 12, 2009

LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL

Cleared Sep 13, 2007

DIMER ACID DERIVED NANO-HYBRID COMPOSITE RESTORATIVE MATERIAL

Cleared Aug 03, 2004