Cleared Traditional

Choice 2 DC

K250156 · Bisco, Inc. · Dental
Jul 2025
Decision
171d
Days
Class 2
Risk

About This 510(k) Submission

K250156 is an FDA 510(k) clearance for the Choice 2 DC, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on July 11, 2025, 171 days after receiving the submission on January 21, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K250156 FDA.gov
FDA Decision Cleared SESE
Date Received January 21, 2025
Decision Date July 11, 2025
Days to Decision 171 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EMA — Cement, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3275