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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 128d · 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 143
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K130601.
TRC-PASTE
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MM-SEAL
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MTA CEMENTS
K130125 · S&C Polymer Silicon- Und Composite Spezialitaeten · Jul 2013
MTA2 ROOT AND PULP MATERIALS
K122892 · Avalon Biomed, Inc. · Dec 2012
MTA-FILLAPEX
K113568 · Paxmed International · Aug 2012