Cleared Traditional

INCORIS ZI

K123664 · Sirona Dental Systems GmbH · Dental
Apr 2013
Decision
131d
Days
Class 2
Risk

About This 510(k) Submission

K123664 is an FDA 510(k) clearance for the INCORIS ZI, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Sirona Dental Systems GmbH (Bensheim, DE). The FDA issued a Cleared decision on April 8, 2013, 131 days after receiving the submission on November 28, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number K123664 FDA.gov
FDA Decision Cleared SESE
Date Received November 28, 2012
Decision Date April 08, 2013
Days to Decision 131 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EIH — Powder, Porcelain
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.6660

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