Cleared Traditional

Gradual Dental Zirconia Blank

K231687 · Liaoning Upcera Co., Ltd. · Dental
Sep 2023
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K231687 is an FDA 510(k) clearance for the Gradual Dental Zirconia Blank, 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 7, 2023, 90 days after receiving the submission on June 9, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number K231687 FDA.gov
FDA Decision Cleared SESE
Date Received June 09, 2023
Decision Date September 07, 2023
Days to Decision 90 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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