Cleared Special

K022796 - CERCON CERAM S PORCELAIN

K022796 is the FDA 510(k) clearance for CERCON CERAM S PORCELAIN by Dentsply Intl.. It is a Class 2 Dental device (product code EIH) cleared through the Special 510(k) pathway after a 14-day FDA review.

K022796 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
14d
Days
Class 2
Risk

K022796 is an FDA 510(k) clearance for the CERCON CERAM S PORCELAIN. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on September 6, 2002 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Dentsply Intl. devices

Submission Details

510(k) Number K022796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2002
Decision Date September 06, 2002
Days to Decision 14 days
Submission Type Special
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
113d faster than avg
Panel avg: 127d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

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 277
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K022796.
VINTAGE AL
K032165 · Shofu Dental Corp. · Sep 2003
IMAGINE REFLEX
K031326 · Wieland Dental + Technik GmbH & Co. KG · Jun 2003
VITA IN-CERAM YZ CUBES FOR CEREC
K022996 · Vident · Oct 2002
IMAGINE H.E. PRESS DESIGN-CERAMIC
K020774 · Wieland Dental + Technik GmbH & Co. KG · May 2002
ERIS LAYERING MATERIALS
K012174 · Ivoclar North America, Inc. · Aug 2001
AVANTE MICRO CRYSTAL SYSTEM
K012231 · Jeneric/Pentron, Inc. · Aug 2001