Cleared Traditional

Shofu Block HC Hard

K200470 · Shofu Dental Corporation · Dental
Feb 2021
Decision
345d
Days
Class 2
Risk

About This 510(k) Submission

K200470 is an FDA 510(k) clearance for the Shofu Block HC Hard, 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 February 5, 2021, 345 days after receiving the submission on February 26, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K200470 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 2020
Decision Date February 05, 2021
Days to Decision 345 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