Cleared Traditional

ACTIV VARNISH

K112946 · Pulpdent Corporation · Dental
Dec 2011
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K112946 is an FDA 510(k) clearance for the ACTIV VARNISH, a Varnish, Cavity (Class II — Special Controls, product code LBH), submitted by Pulpdent Corporation (Watertown, US). The FDA issued a Cleared decision on December 9, 2011, 66 days after receiving the submission on October 4, 2011. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number K112946 FDA.gov
FDA Decision Cleared SESE
Date Received October 04, 2011
Decision Date December 09, 2011
Days to Decision 66 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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