Cleared Traditional

PULPDENT COPAL VARNISH WITH FLUORIDE

K100503 · Pulpdent Corporation · Dental
May 2010
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K100503 is an FDA 510(k) clearance for the PULPDENT COPAL VARNISH WITH FLUORIDE, a Varnish, Cavity (Class II — Special Controls, product code LBH), submitted by Pulpdent Corporation (Watertown, US). The FDA issued a Cleared decision on May 12, 2010, 79 days after receiving the submission on February 22, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number K100503 FDA.gov
FDA Decision Cleared SESE
Date Received February 22, 2010
Decision Date May 12, 2010
Days to Decision 79 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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