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FDA 510(k)

ORTHO MTA (MINERAL TRIOXIDE AGGREGATE)

K-Number: K102575 · 2010-10-29

ApplicantDo Co., Ltd.
Decision Date2010-10-29
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHO MTA (MINERAL TRIOXIDE AGGREGATE) is the device name listed in this FDA 510(k) record. The listed applicant is Do Co., Ltd.. It received FDA 510(k) clearance on 2010-10-29 under 510(k) number K102575. 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 ORTHO MTA (MINERAL TRIOXIDE AGGREGATE)?

ORTHO MTA (MINERAL TRIOXIDE AGGREGATE) is a medical device that received FDA 510(k) clearance on 2010-10-29. The listed applicant is Do Co., Ltd.. The 510(k) number is K102575.

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

ORTHO MTA (MINERAL TRIOXIDE AGGREGATE) received FDA 510(k) clearance on 2010-10-29, under 510(k) number K102575.

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

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

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

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

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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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