Cleared Traditional

Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active

K240660 · Kulzer, LLC · Dental

Sep 2024

Decision

193d

Days

Class 2

Risk

About This 510(k) Submission

K240660 is an FDA 510(k) clearance for the Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active, 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 17, 2024, 193 days after receiving the submission on March 8, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number	K240660 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 08, 2024
Decision Date	September 17, 2024
Days to Decision	193 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF