Cleared Abbreviated

K130601 - BIOROOT RCS

K130601 is an FDA 510(k) clearance for BIOROOT RCS, manufactured by Novocol, Inc.. The device is a Class 2 Dental device with product code KIF cleared through the Abbreviated 510(k) pathway after a 224-day FDA review.

K130601 · Novocol, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
224d
Days
Class 2
Risk

K130601 is an FDA 510(k) clearance for the BIOROOT RCS. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Novocol, Inc. (Louisville, US). The FDA issued a Cleared decision on October 17, 2013 after a review of 224 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Novocol, Inc. devices

FDA 510(k) Submission Details - K130601

510(k) Number K130601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2013
Decision Date October 17, 2013
Days to Decision 224 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 127d · This submission: 224d
Pathway characteristics
Standards-based clearance path.

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 92
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K130601.
BIO-C SEALER
K172701 · Angelus Industria DE Produtos Odontologicos S/A · Jan 2018
Well-Root ST
K170950 · Vericom Co., Ltd. · Dec 2017
PROROOT MTA WHITE, PROROOT MTA GRAY
K142178 · Dentsply International, Inc. · Feb 2015
REALSEAL XT SEALER
K102163 · Kerr Corporation · Oct 2010
WELL-PASTE
K090992 · Vericom Co., Ltd. · Apr 2009
ROOT CANAL XR
K083062 · S & C Polymer GmbH · Mar 2009