Cleared Traditional

White ENDOSEAL MTA

K202015 · Maruchi · Dental

Mar 2021

Decision

246d

Days

Class 2

Risk

About This 510(k) Submission

K202015 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 March 24, 2021, 246 days after receiving the submission on July 21, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3820.

Submission Details

510(k) Number	K202015 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 21, 2020
Decision Date	March 24, 2021
Days to Decision	246 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF