Cleared Traditional

ASCENT PORCELAIN PRIMER, MODEL 006-00078, 00600079

K091300 · CAO Group, Inc. · Dental
Jul 2009
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K091300 is an FDA 510(k) clearance for the ASCENT PORCELAIN PRIMER, MODEL 006-00078, 00600079, 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 July 23, 2009, 80 days after receiving the submission on May 4, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K091300 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 2009
Decision Date July 23, 2009
Days to Decision 80 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