Cleared Special

White Endoseal MTA

K212229 · Maruchi · Dental
Aug 2021
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K212229 is an FDA 510(k) clearance for the White 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 August 13, 2021, 28 days after receiving the submission on July 16, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3820.

Submission Details

510(k) Number K212229 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 2021
Decision Date August 13, 2021
Days to Decision 28 days
Submission Type Special
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