Cleared Traditional

Fit SA

K182869 · Shofu Dental Corporation · Dental
Jan 2019
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K182869 is an FDA 510(k) clearance for the Fit SA, 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 January 9, 2019, 89 days after receiving the submission on October 12, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K182869 FDA.gov
FDA Decision Cleared SESE
Date Received October 12, 2018
Decision Date January 09, 2019
Days to Decision 89 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