Cleared Traditional

INCORIS ZI

K062509 · Sirona Dental Systems GmbH · Dental
Sep 2006
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K062509 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 September 12, 2006, 15 days after receiving the submission on August 28, 2006. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number K062509 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 2006
Decision Date September 12, 2006
Days to Decision 15 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

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

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