Cleared Traditional

FILTEK BULK FILL POSTERIOR RESTROATIVE

K141081 · 3M Espe Dental Products · Dental
May 2014
Decision
13d
Days
Class 2
Risk

About This 510(k) Submission

K141081 is an FDA 510(k) clearance for the FILTEK BULK FILL POSTERIOR RESTROATIVE, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by 3M Espe Dental Products (Saint Paul, US). The FDA issued a Cleared decision on May 8, 2014, 13 days after receiving the submission on April 25, 2014. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K141081 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 2014
Decision Date May 08, 2014
Days to Decision 13 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