Cleared Traditional

Stela Automix System

K222581 · Sdi Limited · Dental
Oct 2022
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K222581 is an FDA 510(k) clearance for the Stela Automix System, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Sdi Limited (Melbourne, AU). The FDA issued a Cleared decision on October 28, 2022, 63 days after receiving the submission on August 26, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K222581 FDA.gov
FDA Decision Cleared SESE
Date Received August 26, 2022
Decision Date October 28, 2022
Days to Decision 63 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