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FDA 510(k)

MTA ROOT CANAL SEALER

K-Number: K080203 · 2008-03-26

ApplicantDentsply Interntional
Decision Date2008-03-26
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MTA ROOT CANAL SEALER is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Interntional. It received FDA 510(k) clearance on 2008-03-26 under 510(k) number K080203. 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 ROOT CANAL SEALER?

MTA ROOT CANAL SEALER is a medical device that received FDA 510(k) clearance on 2008-03-26. The listed applicant is Dentsply Interntional. The 510(k) number is K080203.

When did MTA ROOT CANAL SEALER receive FDA 510(k) clearance?

MTA ROOT CANAL SEALER received FDA 510(k) clearance on 2008-03-26, under 510(k) number K080203.

Who is the listed applicant for MTA ROOT CANAL SEALER?

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

What is the FDA product code for MTA ROOT CANAL SEALER?

The FDA product code for MTA ROOT CANAL SEALER is KIF.

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Other records listing Dentsply Interntional as applicant

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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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