Cleared Traditional

ASCENT BOND UNIVERSAL ADHESIVE SYSTEM, MODELS 006-00029, 006-00030, 006-00044, 006-00045

K092616 · CAO Group, Inc. · Dental

Oct 2009

Decision

56d

Days

Class 2

Risk

About This 510(k) Submission

K092616 is an FDA 510(k) clearance for the ASCENT BOND UNIVERSAL ADHESIVE SYSTEM, MODELS 006-00029, 006-00030, 006-00044, 006-00045, 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 October 21, 2009, 56 days after receiving the submission on August 26, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number	K092616 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 26, 2009
Decision Date	October 21, 2009
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF