Cleared Special

K071106 - ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399

K071106 is an FDA 510(k) clearance for ENDOREZ OBTURATION KIT (WITH ACCELERATOR), manufactured by Ultradent Products, Inc.. The device is a Class 2 Dental device with product code KIF cleared through the Special 510(k) pathway after a 19-day FDA review.

K071106 · Ultradent Products, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
19d
Days
Class 2
Risk

K071106 is an FDA 510(k) clearance for the ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (RE.... 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 May 8, 2007 after a review of 19 days - a notably fast clearance cycle.

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

FDA 510(k) Submission Details - K071106

510(k) Number K071106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2007
Decision Date May 08, 2007
Days to Decision 19 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
109d faster than avg
Panel avg: 128d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

KIF Device Classification - Class 2, Special Controls

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 146
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K071106.
MTA ROOT CANAL SEALER
K080203 · Dentsply Interntional · Mar 2008
WELL-PEX
K080266 · Vericom Co., Ltd. · Feb 2008
MTA ADVANCED MATERIAL
K073218 · Dentsply Interntional · Jan 2008
EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM
K063856 · Essential Dental Systems, Inc. · Feb 2007
BIOAGGREGATE
K063422 · Innovative Bioceramix, Inc. · Nov 2006
SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE
K060889 · Pentron Clinical Technologies · Oct 2006
K071106 · ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399
Download PDF FDA Summary Ultradent Products, I…