Cleared Traditional

Tooth Shade Resin Material

K162323 · Liaoning Upcera Co., Ltd. · Dental
Jan 2017
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K162323 is an FDA 510(k) clearance for the Tooth Shade Resin Material, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Liaoning Upcera Co., Ltd. (Benxi, CN). The FDA issued a Cleared decision on January 12, 2017, 146 days after receiving the submission on August 19, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K162323 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 2016
Decision Date January 12, 2017
Days to Decision 146 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690