Cleared Traditional

CORE-FLO D/C

K093470 · Bisco, Inc. · Dental
Feb 2010
Decision
103d
Days
Class 2
Risk

About This 510(k) Submission

K093470 is an FDA 510(k) clearance for the CORE-FLO D/C, 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 February 17, 2010, 103 days after receiving the submission on November 6, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K093470 FDA.gov
FDA Decision Cleared SESE
Date Received November 06, 2009
Decision Date February 17, 2010
Days to Decision 103 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