Cleared Traditional

LC ChromeFlow

K222445 · S&C Polymer Silicon- Und Composite Spezialitaten GmbH · Dental
Mar 2023
Decision
203d
Days
Class 2
Risk

About This 510(k) Submission

K222445 is an FDA 510(k) clearance for the LC ChromeFlow, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by S&C Polymer Silicon- Und Composite Spezialitaten GmbH (Elmshorn, DE). The FDA issued a Cleared decision on March 6, 2023, 203 days after receiving the submission on August 15, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K222445 FDA.gov
FDA Decision Cleared SESE
Date Received August 15, 2022
Decision Date March 06, 2023
Days to Decision 203 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