Cleared Special

Venus Bulk Flow ONE

K220605 · Kulzer, LLC · Dental
Apr 2022
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K220605 is an FDA 510(k) clearance for the Venus Bulk Flow ONE, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Kulzer, LLC (South Bend, US). The FDA issued a Cleared decision on April 21, 2022, 50 days after receiving the submission on March 2, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K220605 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 2022
Decision Date April 21, 2022
Days to Decision 50 days
Submission Type Special
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