Cleared Traditional

K113568 - MTA-FILLAPEX

K113568 is an FDA 510(k) clearance for MTA-FILLAPEX, manufactured by Paxmed International. The device is a Class 2 Dental device with product code KIF cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K113568 · Paxmed International · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
263d
Days
Class 2
Risk

K113568 is an FDA 510(k) clearance for the MTA-FILLAPEX. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Paxmed International (San Diego, US). The FDA issued a Cleared decision on August 21, 2012 after a review of 263 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.

FDA 510(k) Submission Details - K113568

510(k) Number K113568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2011
Decision Date August 21, 2012
Days to Decision 263 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
135d slower than avg
Panel avg: 128d · This submission: 263d
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 143
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K113568.
BIOROOT RCS
K130601 · Novocol, Inc. · Oct 2013
MTA CEMENTS
K130125 · S&C Polymer Silicon- Und Composite Spezialitaeten · Jul 2013
MTA2 ROOT AND PULP MATERIALS
K122892 · Avalon Biomed, Inc. · Dec 2012
DRFP PROPOINTS, PROPOINTS 4%, PROPOINTS 6%, PROPOINTS PT, PROPOINTS S
K120048 · Drfp , Ltd. · Jun 2012
ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE)
K112078 · Maruchi · Mar 2012
MTA ANGELUS
K112046 · Angelus Industria DE Productos Odontologicos · Jan 2012
K113568 · MTA-FILLAPEX
Download PDF FDA Summary Paxmed International