Cleared Traditional

K112152 - CERCON HT

K112152 is an FDA 510(k) clearance for CERCON HT, manufactured by Dentsply International, Inc.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K112152 · Dentsply International, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
105d
Days
Class 2
Risk

K112152 is an FDA 510(k) clearance for the CERCON HT. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Dentsply International, Inc. (York, US). The FDA issued a Cleared decision on November 9, 2011 after a review of 105 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 International, Inc. devices

FDA 510(k) Submission Details - K112152

510(k) Number K112152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2011
Decision Date November 09, 2011
Days to Decision 105 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
22d faster than avg
Panel avg: 127d · This submission: 105d
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 399
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K112152.
HILLA DIGITAL TRANSFERS
K113575 · Hilla Technologies, Inc. · Mar 2012
HEISENBERG EFFECT SHADES
K120011 · 3M Espe AG · Jan 2012
JENSEN ZIRCONIA
K112806 · Jensen Industries, Inc. · Dec 2011
ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZR
K112710 · Wieland Dental + Technik GmbH & Co. KG · Oct 2011
THE INSYNC CERAMIC SYSTEM
K111743 · Jensen Industries, Inc. · Sep 2011
MONOBLOC BM SERIES
K111573 · Hass Corp. · Aug 2011