Endocem MTA Premixed Regular
K-Number: K213757 · 2023-02-14
ApplicantMaruchi
Decision Date2023-02-14
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Endocem MTA Premixed Regular is a medical device manufactured by Maruchi. It received FDA 510(k) clearance on 2023-02-14 under approval number K213757. 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 Premixed Regular?
Endocem MTA Premixed Regular is a medical device that received FDA 510(k) clearance on 2023-02-14. It is manufactured by Maruchi. The 510(k) number is K213757.
When was Endocem MTA Premixed Regular approved by the FDA?
Endocem MTA Premixed Regular received FDA 510(k) clearance on 2023-02-14, under approval number K213757.
What company makes Endocem MTA Premixed Regular?
Endocem MTA Premixed Regular is manufactured by Maruchi.
What is the FDA product code for Endocem MTA Premixed Regular?
The FDA product code for Endocem MTA Premixed Regular is KIF.
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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.