Cleared Traditional

ASCENT DENTAL CLEANSER

K070070 · CAO Group, Inc. · Dental
May 2007
Decision
137d
Days
Class 2
Risk

About This 510(k) Submission

K070070 is an FDA 510(k) clearance for the ASCENT DENTAL CLEANSER, a Varnish, Cavity (Class II — Special Controls, product code LBH), submitted by CAO Group, Inc. (West Jordan, US). The FDA issued a Cleared decision on May 25, 2007, 137 days after receiving the submission on January 8, 2007. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number K070070 FDA.gov
FDA Decision Cleared SESE
Date Received January 08, 2007
Decision Date May 25, 2007
Days to Decision 137 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LBH — Varnish, Cavity
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3260

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