Cleared Traditional

BEAUTIFIL II Gingiva

K151700 · Shofu Dental Corporation · Dental
Mar 2016
Decision
252d
Days
Class 2
Risk

About This 510(k) Submission

K151700 is an FDA 510(k) clearance for the BEAUTIFIL II Gingiva, 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 March 2, 2016, 252 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 K151700 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 2015
Decision Date March 02, 2016
Days to Decision 252 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