Cleared Special

CERCON CERAM EXPRESS CERAMIC SYSTEM (K041707) - FDA 510(k) Clearance

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K041707 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
37d
Days
Class 2
Risk

K041707 is an FDA 510(k) clearance for the CERCON CERAM EXPRESS CERAMIC SYSTEM. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on July 30, 2004 after a review of 37 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 K041707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2004
Decision Date July 30, 2004
Days to Decision 37 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
90d faster than avg
Panel avg: 127d · This submission: 37d
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 164
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K041707.
CARRARA VOLUMIA
K070019 · Dentsply Intl. · Jan 2007
MODIFICATION TO: CERCON BASE
K051462 · Dentsply Intl. · Jun 2005
DUCERA ALLCERAM
K043247 · Dentsply Intl. · Dec 2004
CARRARA INTERACTION CERAMIC SYSTEM
K040635 · Dentsply Intl. · Mar 2004
DUCERAM PLUS CERAMIC SYSTEM
K040420 · Dentsply Intl. · Mar 2004
DUCERAGOLD PORCELAINS
K040421 · Dentsply Intl. · Mar 2004