Cleared Traditional

Upcera Glaze Paste, Glaze Powder, and Glaze Liquid

K181167 · Liaoning Upcera Co., Ltd. · Dental
Sep 2018
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K181167 is an FDA 510(k) clearance for the Upcera Glaze Paste, Glaze Powder, and Glaze Liquid, 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 September 2, 2018, 123 days after receiving the submission on May 2, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number K181167 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2018
Decision Date September 02, 2018
Days to Decision 123 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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