Cleared Traditional

Signum opaque F

K230644 · Kulzer, LLC · Dental
Sep 2023
Decision
183d
Days
Class 2
Risk

About This 510(k) Submission

K230644 is an FDA 510(k) clearance for the Signum opaque F, 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 September 7, 2023, 183 days after receiving the submission on March 8, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K230644 FDA.gov
FDA Decision Cleared SESE
Date Received March 08, 2023
Decision Date September 07, 2023
Days to Decision 183 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