Cleared Traditional

K123615 - IRIS - HIGH STRENGTH GLASS CERAMIC

K123615 is an FDA 510(k) clearance for IRIS - HIGH STRENGTH GLASS CERAMIC, manufactured by Dentsply Intl.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K123615 · Dentsply Intl. · Dental device
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Feb 2013
Decision
91d
Days
Class 2
Risk

K123615 is an FDA 510(k) clearance for the IRIS - HIGH STRENGTH GLASS CERAMIC. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on February 22, 2013 after a review of 91 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 Dentsply Intl. devices

FDA 510(k) Submission Details - K123615

510(k) Number K123615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2012
Decision Date February 22, 2013
Days to Decision 91 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
36d faster than avg
Panel avg: 127d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EIH Device Classification - Class 2, Special Controls

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 431
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K123615.
BRUXZIR SHADED
K130924 · Prismatik Dentalcraft, Inc. · May 2013
INCORIS ZI
K123664 · Sirona Dental Systems GmbH · Apr 2013
CEREC BLOCS C IN
K123952 · Sirona Dental Systems GmbH · Mar 2013
COPRANCOLOR
K123680 · White Peaks Dental Systems GmbH & Co. KG · Feb 2013
SYNSPAR ADVANCED
K123613 · Ardent, Inc. · Feb 2013
INCORIS TZI
K123545 · Sirona Dental Systems GmbH · Feb 2013