Cleared Special

K140955 - MTA2.1 MATERIAL

K140955 is an FDA 510(k) clearance for MTA2.1 MATERIAL, manufactured by Avalon Biomed, Inc.. The device is a Class 2 Dental device with product code KIF cleared through the Special 510(k) pathway after a 58-day FDA review.

K140955 · Avalon Biomed, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
58d
Days
Class 2
Risk

K140955 is an FDA 510(k) clearance for the MTA2.1 MATERIAL. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Avalon Biomed, Inc. (Bradenton, US). The FDA issued a Cleared decision on June 11, 2014 after a review of 58 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 - K140955

510(k) Number K140955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2014
Decision Date June 11, 2014
Days to Decision 58 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
70d faster than avg
Panel avg: 128d · This submission: 58d
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.

Regulatory Peers - KIF Resin, Root Canal Filling

All 141
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K140955.
PROROOT MTA WHITE, PROROOT MTA GRAY
K142178 · Dentsply International, Inc. · Feb 2015
IROOT FM
K130312 · Innovative Bioceramix, Inc. · Sep 2014
BIODENTINE
K140132 · Septodont · Jun 2014
ENDOCEM ZR
K133042 · Maruchi · May 2014
ENDOSEAL
K133054 · Maruchi · May 2014
MTA FILLAPEX
K140247 · Angelus Industria DE Productos Odontologicos SA · Apr 2014