Cleared Traditional

QUELL DESENSITIZER

K010957 · Jeneric/Pentron, Inc. · Dental
Jun 2001
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K010957 is an FDA 510(k) clearance for the QUELL DESENSITIZER, a Varnish, Cavity (Class II — Special Controls, product code LBH), submitted by Jeneric/Pentron, Inc. (Wallingford, US). The FDA issued a Cleared decision on June 25, 2001, 87 days after receiving the submission on March 30, 2001. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number K010957 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 2001
Decision Date June 25, 2001
Days to Decision 87 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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