Cleared Traditional

ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE)

K112078 · Maruchi · Dental
Mar 2012
Decision
242d
Days
Class 2
Risk

About This 510(k) Submission

K112078 is an FDA 510(k) clearance for the ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE), a Resin, Root Canal Filling (Class II — Special Controls, product code KIF), submitted by Maruchi (Fullerton, US). The FDA issued a Cleared decision on March 19, 2012, 242 days after receiving the submission on July 21, 2011. This device falls under the Dental review panel. Regulated under 21 CFR 872.3820.

Submission Details

510(k) Number K112078 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code KIF — Resin, Root Canal Filling
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3820