Cleared Special

K994251 - KETAC-MOLAR QUICK

K994251 is the FDA 510(k) clearance for KETAC-MOLAR QUICK by Espe Dental AG. It is a Class 2 Dental device (product code EBF) cleared through the Special 510(k) pathway after a 17-day FDA review.

K994251 · Espe Dental AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
17d
Days
Class 2
Risk

K994251 is an FDA 510(k) clearance for the KETAC-MOLAR QUICK. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Espe Dental AG (Bavaria D-82228 Seefeld, DE). The FDA issued a Cleared decision on January 3, 2000 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 K994251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1999
Decision Date January 03, 2000
Days to Decision 17 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
110d faster than avg
Panel avg: 127d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 584
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K994251.
ARABESK TOP
K994268 · Voco GmbH · Feb 2000
ADMIRA
K994056 · Voco GmbH · Jan 2000
FUJI II LC CAPSULE
K993973 · GC America, Inc. · Jan 2000
SOLITAIRE 2
K993932 · Heraeus Kulzer, Inc. · Dec 1999
PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE
K993716 · Harry J. Bosworth Co. · Dec 1999
PRE-VISION FILL
K993602 · Heraeus Kulzer, Inc. · Dec 1999