Cleared Traditional

Mosaic Universal Composite

K151094 · Ultradent Products, Inc. · Dental
Jul 2015
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K151094 is an FDA 510(k) clearance for the Mosaic Universal Composite, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on July 21, 2015, 89 days after receiving the submission on April 23, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K151094 FDA.gov
FDA Decision Cleared SESE
Date Received April 23, 2015
Decision Date July 21, 2015
Days to Decision 89 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