Cleared Traditional

SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow

K221255 · Kerr Corporation · Dental
Aug 2022
Decision
121d
Days
Class 2
Risk

About This 510(k) Submission

K221255 is an FDA 510(k) clearance for the SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Kerr Corporation (Pomona, US). The FDA issued a Cleared decision on August 31, 2022, 121 days after receiving the submission on May 2, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K221255 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2022
Decision Date August 31, 2022
Days to Decision 121 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690