Cleared Traditional

ENDOSEAL MTA

K170175 · Maruchi · Dental
Feb 2018
Decision
403d
Days
Class 2
Risk

About This 510(k) Submission

K170175 is an FDA 510(k) clearance for the ENDOSEAL MTA, 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 26, 2018, 403 days after receiving the submission on January 19, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.3820.

Submission Details

510(k) Number K170175 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 2017
Decision Date February 26, 2018
Days to Decision 403 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