Medical Device Manufacturer · US , Fullerton , CA

Maruchi - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2012

Recent clearances: Endocem MTA Premixed Regular, White Endoseal MTA, White ENDOSEAL MTA

Total

Cleared

Denied

Maruchi has 8 FDA 510(k) cleared medical devices. Based in Fullerton, US.

Last cleared in 2023. Active since 2012. Primary specialty: Dental.

Browse the FDA 510(k) cleared devices submitted by Maruchi Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by LK Consulting Group USA, Inc. as regulatory consultant.

Maruchi is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Maruchi

8 devices

1-8 of 8

Cleared Feb 14, 2023

Endocem MTA Premixed Regular

ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE)

K112078 · KIF

Dental · 242d

Data Source

Sourced from the FDA 510(k) public files . 175,450 total devices indexed.

Last updated: May 14, 2026

Maruchi - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Maruchi

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