Cleared Traditional

Endocem MTA Premixed Regular

K213757 · Maruchi · Dental
Feb 2023
Decision
441d
Days
Class 2
Risk

About This 510(k) Submission

K213757 is an FDA 510(k) clearance for the Endocem MTA Premixed Regular, a Resin, Root Canal Filling (Class II — Special Controls, product code KIF), submitted by Maruchi (Wonju-Si, KR). The FDA issued a Cleared decision on February 14, 2023, 441 days after receiving the submission on November 30, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3820.

Submission Details

510(k) Number K213757 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 2021
Decision Date February 14, 2023
Days to Decision 441 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