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FDA 510(k)

White Endoseal MTA

K-Number: K212229 · 2021-08-13

ApplicantMaruchi
Decision Date2021-08-13
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

White Endoseal MTA is a medical device manufactured by Maruchi. It received FDA 510(k) clearance on 2021-08-13 under approval number K212229. 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 White Endoseal MTA?

White Endoseal MTA is a medical device that received FDA 510(k) clearance on 2021-08-13. It is manufactured by Maruchi. The 510(k) number is K212229.

When was White Endoseal MTA approved by the FDA?

White Endoseal MTA received FDA 510(k) clearance on 2021-08-13, under approval number K212229.

What company makes White Endoseal MTA?

White Endoseal MTA is manufactured by Maruchi.

What is the FDA product code for White Endoseal MTA?

The FDA product code for White Endoseal MTA is KIF.

Other Devices by Maruchi

K170175ENDOSEAL MTA K202015White ENDOSEAL MTA K201799CleaniCal K213757Endocem MTA Premixed Regular

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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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