Cleared Traditional

BEAUTIFIL II LS

K160596 · Shofu Dental Corporation · Dental
Jul 2016
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K160596 is an FDA 510(k) clearance for the BEAUTIFIL II LS, 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 July 27, 2016, 147 days after receiving the submission on March 2, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K160596 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 2016
Decision Date July 27, 2016
Days to Decision 147 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