Cleared Traditional

Quantium

K242816 · Bisco, Inc. · Dental
Dec 2024
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K242816 is an FDA 510(k) clearance for the Quantium, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on December 17, 2024, 90 days after receiving the submission on September 18, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K242816 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 2024
Decision Date December 17, 2024
Days to Decision 90 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