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FDA 510(k)

WHITE MTA MATERIAL

K-Number: K011009 · 2001-05-02

ApplicantDentsply International
Decision Date2001-05-02
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

WHITE MTA MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply International. It received FDA 510(k) clearance on 2001-05-02 under 510(k) number K011009. 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 MTA MATERIAL?

WHITE MTA MATERIAL is a medical device that received FDA 510(k) clearance on 2001-05-02. The listed applicant is Dentsply International. The 510(k) number is K011009.

When did WHITE MTA MATERIAL receive FDA 510(k) clearance?

WHITE MTA MATERIAL received FDA 510(k) clearance on 2001-05-02, under 510(k) number K011009.

Who is the listed applicant for WHITE MTA MATERIAL?

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

What is the FDA product code for WHITE MTA MATERIAL?

The FDA product code for WHITE MTA MATERIAL 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.

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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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