Cleared Traditional

ENAMEL PRO VARNISH

K062683 · Premier Dental Products Co. · Dental
Nov 2006
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K062683 is an FDA 510(k) clearance for the ENAMEL PRO VARNISH, a Varnish, Cavity (Class II — Special Controls, product code LBH), submitted by Premier Dental Products Co. (Plymouth Meeting, US). The FDA issued a Cleared decision on November 21, 2006, 74 days after receiving the submission on September 8, 2006. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number K062683 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 2006
Decision Date November 21, 2006
Days to Decision 74 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code LBH — Varnish, Cavity
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3260

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