Cleared Traditional

K151094 - Mosaic Universal Composite (FDA 510(k) Clearance)

K151094 · Ultradent Products, Inc. · Dental device

Jul 2015

Decision

89d

Days

Class 2

Risk

K151094 is an FDA 510(k) clearance for the Mosaic Universal Composite. This device is classified as 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 FDA review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number	K151094 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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