Cleared Traditional

IPS EMPRESS DIRECT FLOW

K103528 · Ivoclar Vivadent, Inc. · Dental
Feb 2011
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K103528 is an FDA 510(k) clearance for the IPS EMPRESS DIRECT FLOW, 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 review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K103528 FDA.gov
FDA Decision Cleared 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

Device Classification

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