Cleared Traditional

BeautiCem Veneer Kit

K180649 · Shofu Dental Corporation · Dental
Jun 2018
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K180649 is an FDA 510(k) clearance for the BeautiCem Veneer Kit, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Shofu Dental Corporation (San Marcos, US). The FDA issued a Cleared decision on June 11, 2018, 90 days after receiving the submission on March 13, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K180649 FDA.gov
FDA Decision Cleared SESE
Date Received March 13, 2018
Decision Date June 11, 2018
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

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