Cleared Special

K140247 - MTA FILLAPEX

K140247 is an FDA 510(k) clearance for MTA FILLAPEX, manufactured by Angelus Industria DE Productos Odontologicos SA. The device is a Class 2 Dental device with product code KIF cleared through the Special 510(k) pathway after a 85-day FDA review.

K140247 · Angelus Industria DE Productos Odontologicos SA · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
85d
Days
Class 2
Risk

K140247 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 Angelus Industria DE Productos Odontologicos SA (Aventura, US). The FDA issued a Cleared decision on April 25, 2014 after a review of 85 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K140247

510(k) Number K140247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2014
Decision Date April 25, 2014
Days to Decision 85 days
Submission Type Special
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
43d faster than avg
Panel avg: 128d · This submission: 85d
Pathway characteristics
Modification to existing cleared device.

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.

K140247 · MTA FILLAPEX
Download PDF FDA Summary Angelus Industria DE …