Cleared Traditional

BEAUTIFIL Flow Plus X

K172530 · Shofu Dental Corporation · Dental
Dec 2017
Decision
107d
Days
Class 2
Risk

About This 510(k) Submission

K172530 is an FDA 510(k) clearance for the BEAUTIFIL Flow Plus X, 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 6, 2017, 107 days after receiving the submission on August 21, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K172530 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 2017
Decision Date December 06, 2017
Days to Decision 107 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