Cleared Special

KETAC CEM U (K002793) - FDA 510(k) Clearance

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

K002793 · Espe Dental AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2000
Decision
19d
Days
Class 2
Risk

K002793 is an FDA 510(k) clearance for the KETAC CEM U. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Espe Dental AG (Bavaria D-82228 Seefeld, DE). The FDA issued a Cleared decision on September 26, 2000 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 Espe Dental AG devices

Submission Details

510(k) Number K002793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2000
Decision Date September 26, 2000
Days to Decision 19 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 127d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 80
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K002793.
GILB, MODEL 8010
K011200 · 3M Company · Jun 2001
DYRACT CEM LCI COMPOMER
K003921 · Dentsply Intl. · Jan 2001
3M RELY X VENEER CEMENT TRY-IN PASTER
K002452 · 3M Company · Sep 2000
FLOWABLE COMPOSITE
K981965 · Dentsply Intl. · Jul 1998
ADHESIVE HYBRID IONOMER CEMENT
K974140 · Dentsply Intl. · Jan 1998
3M DENT SYSTEM II PLUS
K973961 · 3M Company · Dec 1997