Cleared Traditional

3M Filtek Universal Restorative

K183476 · 3M Espe Dental Products · Dental
Jan 2019
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K183476 is an FDA 510(k) clearance for the 3M Filtek Universal Restorative, 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 January 2, 2019, 16 days after receiving the submission on December 17, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K183476 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 2018
Decision Date January 02, 2019
Days to Decision 16 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