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FDA 510(k)

MTA-FILLAPEX

K-Number: K113568 · 2012-08-21

ApplicantPaxmed International
Decision Date2012-08-21
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MTA-FILLAPEX is the device name listed in this FDA 510(k) record. The listed applicant is Paxmed International. It received FDA 510(k) clearance on 2012-08-21 under 510(k) number K113568. 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 MTA-FILLAPEX?

MTA-FILLAPEX is a medical device that received FDA 510(k) clearance on 2012-08-21. The listed applicant is Paxmed International. The 510(k) number is K113568.

When did MTA-FILLAPEX receive FDA 510(k) clearance?

MTA-FILLAPEX received FDA 510(k) clearance on 2012-08-21, under 510(k) number K113568.

Who is the listed applicant for MTA-FILLAPEX?

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

What is the FDA product code for MTA-FILLAPEX?

The FDA product code for MTA-FILLAPEX is KIF.

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Other records listing Paxmed International 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.

K022038SPI ONETIME DENTAL IMPLANTK010467UNIVERSAL DENTAL COPING (UDC)K011223QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM

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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