Cleared Traditional

PRO-V COAT

K103514 · Bisco, Inc. · Dental
May 2011
Decision
176d
Days
Class 2
Risk

About This 510(k) Submission

K103514 is an FDA 510(k) clearance for the PRO-V COAT, a Crown And Bridge, Temporary, Resin (Class II — Special Controls, product code EBG), submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on May 25, 2011, 176 days after receiving the submission on November 30, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.

Submission Details

510(k) Number K103514 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 2010
Decision Date May 25, 2011
Days to Decision 176 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBG — Crown And Bridge, Temporary, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3770

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