Cleared Traditional

K142178 - PROROOT MTA WHITE

K142178 is the FDA 510(k) clearance for PROROOT MTA WHITE by Dentsply International, Inc.. It is a Class 2 Dental device (product code KIF) cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K142178 · Dentsply International, Inc. · Dental device
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Feb 2015
Decision
202d
Days
Class 2
Risk

K142178 is an FDA 510(k) clearance for the PROROOT MTA WHITE, PROROOT MTA GRAY. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Dentsply International, Inc. (York, US). The FDA issued a Cleared decision on February 26, 2015 after a review of 202 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.

View all Dentsply International, Inc. devices

Submission Details

510(k) Number K142178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2014
Decision Date February 26, 2015
Days to Decision 202 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
75d slower than avg
Panel avg: 127d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 74
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K142178.
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ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399
K071106 · Ultradent Products, Inc. · May 2007
CZ-S2000
K060946 · Parkell, Inc. · Jun 2006
ENDOREZ
K042756 · Ultradent Products, Inc. · Oct 2004