Cleared Traditional

NUPRO MODEL 13016901

K103160 · CAO Group, Inc. · Dental
Jan 2011
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K103160 is an FDA 510(k) clearance for the NUPRO MODEL 13016901, 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 January 6, 2011, 72 days after receiving the submission on October 26, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number K103160 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 2010
Decision Date January 06, 2011
Days to Decision 72 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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