Cleared Traditional

FILTEK BULK FILL FLOWABLE RESTORATIVE

K120453 · 3M Espe Dental Products · Dental
Mar 2012
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K120453 is an FDA 510(k) clearance for the FILTEK BULK FILL FLOWABLE RESTORATIVE, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by 3M Espe Dental Products (St. Paul, US). The FDA issued a Cleared decision on March 19, 2012, 34 days after receiving the submission on February 14, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K120453 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 2012
Decision Date March 19, 2012
Days to Decision 34 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