Cleared Traditional

K123664 - INCORIS ZI

K123664 is the FDA 510(k) clearance for INCORIS ZI by Sirona Dental Systems GmbH. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K123664 · Sirona Dental Systems GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
131d
Days
Class 2
Risk

K123664 is an FDA 510(k) clearance for the INCORIS ZI. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Sirona Dental Systems GmbH (Bensheim, DE). The FDA issued a Cleared decision on April 8, 2013 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Sirona Dental Systems GmbH devices

Submission Details

510(k) Number K123664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 127d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EIH Powder, Porcelain

All 272
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K123664.
ZENOLUX
K130184 · Wieland Dental + Technik GmbH & Co. KG · May 2013
VINTAGE MP PRESS OVER
K122614 · Shofu Dental Corporation · May 2013
BRUXZIR SHADED
K130924 · Prismatik Dentalcraft, Inc. · May 2013
CEREC BLOCS C IN
K123952 · Sirona Dental Systems GmbH · Mar 2013
IRIS - HIGH STRENGTH GLASS CERAMIC
K123615 · Dentsply Intl. · Feb 2013
INCORIS TZI
K123545 · Sirona Dental Systems GmbH · Feb 2013