Cleared Traditional

EMPRESS DIRECT

K090701 · Ivoclar Vivadent, Inc. · Dental
Apr 2009
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K090701 is an FDA 510(k) clearance for the EMPRESS DIRECT, 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 review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K090701 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690