Cleared Traditional

VERICORE ZIRCONIA BLANKS

K140877 · Whip-Mix Corp. · Dental
Sep 2014
Decision
149d
Days
Class 2
Risk

About This 510(k) Submission

K140877 is an FDA 510(k) clearance for the VERICORE ZIRCONIA BLANKS, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Whip-Mix Corp. (Louisville, US). The FDA issued a Cleared decision on September 3, 2014, 149 days after receiving the submission on April 7, 2014. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number K140877 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 2014
Decision Date September 03, 2014
Days to Decision 149 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EIH — Powder, Porcelain
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.6660

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