Cleared Traditional

Upcera Dental Zirconia Blank for Aesthetic Restoration

K152175 · Liaoning Upcera Co., Ltd. · Dental
Dec 2015
Decision
122d
Days
Class 2
Risk

About This 510(k) Submission

K152175 is an FDA 510(k) clearance for the Upcera Dental Zirconia Blank for Aesthetic Restoration, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Liaoning Upcera Co., Ltd. (Benxi, CN). The FDA issued a Cleared decision on December 4, 2015, 122 days after receiving the submission on August 4, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number K152175 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 2015
Decision Date December 04, 2015
Days to Decision 122 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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