Cleared Traditional

IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE)

K103556 · Ivoclar Vivadent, Inc. · Dental

Apr 2011

Decision

132d

Days

Class 2

Risk

About This 510(k) Submission

K103556 is an FDA 510(k) clearance for the IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE), a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on April 13, 2011, 132 days after receiving the submission on December 2, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number	K103556 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 02, 2010
Decision Date	April 13, 2011
Days to Decision	132 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement