Cleared Traditional

K090701 - EMPRESS DIRECT (FDA 510(k) Clearance)

K090701 · Ivoclar Vivadent, Inc. · Dental device

Apr 2009

Decision

43d

Days

Class 2

Risk

K090701 is an FDA 510(k) clearance for the EMPRESS DIRECT. 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 April 29, 2009, 43 days after receiving the submission on March 17, 2009.

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

Submission Details

510(k) Number	K090701 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 17, 2009
Decision Date	April 29, 2009
Days to Decision	43 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement