Cleared Traditional

CERAMAGE UP

K162261 · Shofu Dental Corporation · Dental
Jan 2017
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K162261 is an FDA 510(k) clearance for the CERAMAGE UP, 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 January 11, 2017, 153 days after receiving the submission on August 11, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K162261 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 2016
Decision Date January 11, 2017
Days to Decision 153 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