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FDA 510(k)

CLEARFIL MAJESTY ES FLOW

K-Number: K130371 · 2013-04-09

ApplicantKuraray Noritake Dental, Inc.
Decision Date2013-04-09
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CLEARFIL MAJESTY ES FLOW is the device name listed in this FDA 510(k) record. The listed applicant is Kuraray Noritake Dental, Inc.. It received FDA 510(k) clearance on 2013-04-09 under 510(k) number K130371. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEARFIL MAJESTY ES FLOW?

CLEARFIL MAJESTY ES FLOW is a medical device that received FDA 510(k) clearance on 2013-04-09. The listed applicant is Kuraray Noritake Dental, Inc.. The 510(k) number is K130371.

When did CLEARFIL MAJESTY ES FLOW receive FDA 510(k) clearance?

CLEARFIL MAJESTY ES FLOW received FDA 510(k) clearance on 2013-04-09, under 510(k) number K130371.

Who is the listed applicant for CLEARFIL MAJESTY ES FLOW?

The FDA 510(k) record lists Kuraray Noritake Dental, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLEARFIL MAJESTY ES FLOW?

The FDA product code for CLEARFIL MAJESTY ES FLOW is EBF.

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Other records listing Kuraray Noritake Dental, Inc. as applicant

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Related Devices (Code: EBF)

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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