Cleared Traditional

SHOFU Enamel Conditioner

K160086 · Shofu Dental Corporation · Dental
Jul 2016
Decision
188d
Days
Class 2
Risk

About This 510(k) Submission

K160086 is an FDA 510(k) clearance for the SHOFU Enamel Conditioner, 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 21, 2016, 188 days after receiving the submission on January 15, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K160086 FDA.gov
FDA Decision Cleared SESE
Date Received January 15, 2016
Decision Date July 21, 2016
Days to Decision 188 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