Cleared Traditional

UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANK

K141724 · Liaoning Upcera Co., Ltd. · Dental
Oct 2014
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K141724 is an FDA 510(k) clearance for the UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANK, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Liaoning Upcera Co., Ltd. (New Milford, US). The FDA issued a Cleared decision on October 22, 2014, 118 days after receiving the submission on June 26, 2014. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number K141724 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 2014
Decision Date October 22, 2014
Days to Decision 118 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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