Cleared Traditional

ENDOSEAL

K133054 · Maruchi · Dental
May 2014
Decision
227d
Days
Class 2
Risk

About This 510(k) Submission

K133054 is an FDA 510(k) clearance for the ENDOSEAL, a Resin, Root Canal Filling (Class II — Special Controls, product code KIF), submitted by Maruchi (Fullerton, US). The FDA issued a Cleared decision on May 12, 2014, 227 days after receiving the submission on September 27, 2013. This device falls under the Dental review panel. Regulated under 21 CFR 872.3820.

Submission Details

510(k) Number K133054 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2013
Decision Date May 12, 2014
Days to Decision 227 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