Cleared Traditional

K112078 - ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE)

K112078 is an FDA 510(k) clearance for ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE), manufactured by Maruchi. The device is a Class 2 Dental device with product code KIF cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K112078 · Maruchi · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
242d
Days
Class 2
Risk

K112078 is an FDA 510(k) clearance for the ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE). Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Maruchi (Fullerton, US). The FDA issued a Cleared decision on March 19, 2012 after a review of 242 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 Maruchi devices

FDA 510(k) Submission Details - K112078

510(k) Number K112078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2011
Decision Date March 19, 2012
Days to Decision 242 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
114d slower than avg
Panel avg: 128d · This submission: 242d
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 138
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K112078.
MTA2 ROOT AND PULP MATERIALS
K122892 · Avalon Biomed, Inc. · Dec 2012
MTA-FILLAPEX
K113568 · Paxmed International · Aug 2012
DRFP PROPOINTS, PROPOINTS 4%, PROPOINTS 6%, PROPOINTS PT, PROPOINTS S
K120048 · Drfp , Ltd. · Jun 2012
MTA ANGELUS
K112046 · Angelus Industria DE Productos Odontologicos · Jan 2012
IROOT FS
K102867 · Innovative Bioceramix, Inc. · Dec 2010
ORTHO MTA (MINERAL TRIOXIDE AGGREGATE)
K102575 · Do Co., Ltd. · Oct 2010