Cleared Special

K042756 - ENDOREZ

K042756 is the FDA 510(k) clearance for ENDOREZ by Ultradent Products, Inc.. It is a Class 2 Dental device (product code KIF) cleared through the Special 510(k) pathway after a 22-day FDA review.

K042756 · Ultradent Products, Inc. · Dental device
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Oct 2004
Decision
22d
Days
Class 2
Risk

K042756 is an FDA 510(k) clearance for the ENDOREZ. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on October 26, 2004 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3820 - 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 Ultradent Products, Inc. devices

Submission Details

510(k) Number K042756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2004
Decision Date October 26, 2004
Days to Decision 22 days
Submission Type Special
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 127d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KIF Resin, Root Canal Filling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3820
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 - KIF Resin, Root Canal Filling

All 74
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K042756.
PROROOT MTA WHITE, PROROOT MTA GRAY
K142178 · Dentsply International, Inc. · Feb 2015
ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399
K071106 · Ultradent Products, Inc. · May 2007
CZ-S2000
K060946 · Parkell, Inc. · Jun 2006
DIAPEX
K033585 · Bisco, Inc. · Jan 2004
FIRST FILL R.C.S.
K011748 · Jeneric/Pentron, Inc. · Aug 2001
SEALAPEX 4
K010940 · Sybron Dental Specialties, Inc. · Jun 2001