Cleared Traditional

K063856 - EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM

K063856 is an FDA 510(k) clearance for EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT ..., manufactured by Essential Dental Systems, Inc.. The device is a Class 2 Dental device with product code KIF cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K063856 · Essential Dental Systems, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
40d
Days
Class 2
Risk

K063856 is an FDA 510(k) clearance for the EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Essential Dental Systems, Inc. (Great Neck, US). The FDA issued a Cleared decision on February 6, 2007 after a review of 40 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Essential Dental Systems, Inc. devices

FDA 510(k) Submission Details - K063856

510(k) Number K063856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2006
Decision Date February 06, 2007
Days to Decision 40 days
Submission Type Traditional
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
88d faster than avg
Panel avg: 128d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 138
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K063856.
WELL-PEX
K080266 · Vericom Co., Ltd. · Feb 2008
MTA ADVANCED MATERIAL
K073218 · Dentsply Interntional · Jan 2008
ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399
K071106 · Ultradent Products, Inc. · May 2007
BIOAGGREGATE
K063422 · Innovative Bioceramix, Inc. · Nov 2006
SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE
K060889 · Pentron Clinical Technologies · Oct 2006
CZ-S2000
K060946 · Parkell, Inc. · Jun 2006