Cleared Traditional

ASCENT F-COAT MODEL: 006-00097

K100540 · CAO Group, Inc. · Dental
Sep 2010
Decision
210d
Days
Class 2
Risk

About This 510(k) Submission

K100540 is an FDA 510(k) clearance for the ASCENT F-COAT MODEL: 006-00097, 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 September 23, 2010, 210 days after receiving the submission on February 25, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number K100540 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 2010
Decision Date September 23, 2010
Days to Decision 210 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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