Cleared Traditional

BEAUTIFIL II Enamel

K151699 · Shofu Dental Corporation · Dental
Dec 2015
Decision
169d
Days
Class 2
Risk

About This 510(k) Submission

K151699 is an FDA 510(k) clearance for the BEAUTIFIL II Enamel, 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 December 10, 2015, 169 days after receiving the submission on June 24, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K151699 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 2015
Decision Date December 10, 2015
Days to Decision 169 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