Cleared Traditional

K060889 - SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE

K060889 is an FDA 510(k) clearance for SE EPIPHANY ROOT CANAL SEALANT, manufactured by Pentron Clinical Technologies. The device is a Class 2 Dental device with product code KIF cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K060889 · Pentron Clinical Technologies · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
210d
Days
Class 2
Risk

K060889 is an FDA 510(k) clearance for the SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Pentron Clinical Technologies (Wallingford, US). The FDA issued a Cleared decision on October 27, 2006 after a review of 210 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Pentron Clinical Technologies devices

FDA 510(k) Submission Details - K060889

510(k) Number K060889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2006
Decision Date October 27, 2006
Days to Decision 210 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 127d · This submission: 210d
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 97
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K060889.
WELL-PEX
K080266 · Vericom Co., Ltd. · Feb 2008
ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399
K071106 · Ultradent Products, Inc. · May 2007
EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM
K063856 · Essential Dental Systems, Inc. · Feb 2007
CZ-S2000
K060946 · Parkell, Inc. · Jun 2006
ADSEAL ROOT CANAL SEALER
K042769 · Meta Biomed Co., Ltd. · Nov 2004
ENDOREZ
K042756 · Ultradent Products, Inc. · Oct 2004