Cleared Traditional

ASCENT UNIVERSAL ADHESIVE, MODEL 006-00028

K070413 · CAO Group, Inc. · Dental
Apr 2007
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K070413 is an FDA 510(k) clearance for the ASCENT UNIVERSAL ADHESIVE, MODEL 006-00028, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by CAO Group, Inc. (West Jordan, US). The FDA issued a Cleared decision on April 26, 2007, 73 days after receiving the submission on February 12, 2007. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K070413 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 2007
Decision Date April 26, 2007
Days to Decision 73 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KLE — Agent, Tooth Bonding, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3200