Cleared Traditional

SUPER SEAL TOOTH DESENSITIZER

K120109 · Phoenix Dental, Inc. · Dental
Mar 2012
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K120109 is an FDA 510(k) clearance for the SUPER SEAL TOOTH DESENSITIZER, a Varnish, Cavity (Class II — Special Controls, product code LBH), submitted by Phoenix Dental, Inc. (Fenton, US). The FDA issued a Cleared decision on March 7, 2012, 54 days after receiving the submission on January 13, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number K120109 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 2012
Decision Date March 07, 2012
Days to Decision 54 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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