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FDA 510(k)

ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE)

K-Number: K112078 · 2012-03-19

ApplicantMaruchi
Decision Date2012-03-19
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE) is the device name listed in this FDA 510(k) record. The listed applicant is Maruchi. It received FDA 510(k) clearance on 2012-03-19 under 510(k) number K112078. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE)?

ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE) is a medical device that received FDA 510(k) clearance on 2012-03-19. The listed applicant is Maruchi. The 510(k) number is K112078.

When did ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE) receive FDA 510(k) clearance?

ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE) received FDA 510(k) clearance on 2012-03-19, under 510(k) number K112078.

Who is the listed applicant for ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE)?

The FDA 510(k) record lists Maruchi as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE)?

The FDA product code for ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE) is KIF.

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Other records listing Maruchi as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213757Endocem MTA Premixed RegularK212229White Endoseal MTAK202015White ENDOSEAL MTAK201799CleaniCalK170175ENDOSEAL MTA

Related Devices (Code: KIF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262050Vioseal XSpident Co., Ltd.K253909NeoPEX™ Pre-Mixed Obturation PasteNuSmile, Ltd.K261514Calcium Hydroxide Temporary Filling Material (KP-Cal)Guilin Kevin Peter Technology Co., Ltd.K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., Ltd.K253167Any-PasteMediclus Co., Ltd.K252890ZenSeal ProKerr Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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