Cleared Traditional

K103528 - IPS EMPRESS DIRECT FLOW (FDA 510(k) Clearance)

K103528 · Ivoclar Vivadent, Inc. · Dental device

Feb 2011

Decision

87d

Days

Class 2

Risk

K103528 is an FDA 510(k) clearance for the IPS EMPRESS DIRECT FLOW. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).

Submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on February 25, 2011, 87 days after receiving the submission on November 30, 2010.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number	K103528 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 30, 2010
Decision Date	February 25, 2011
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement