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FDA 510(k)

CLEARFIL MAJESTY ES Flow

K-Number: K191980 · 2019-11-18

ApplicantKuraray Noritake Dental, Inc.
Decision Date2019-11-18
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CLEARFIL MAJESTY ES Flow is a medical device manufactured by Kuraray Noritake Dental, Inc.. It received FDA 510(k) clearance on 2019-11-18 under approval number K191980. 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 2019-11-18. It is manufactured by Kuraray Noritake Dental, Inc.. The 510(k) number is K191980.

When was CLEARFIL MAJESTY ES Flow approved by the FDA?

CLEARFIL MAJESTY ES Flow received FDA 510(k) clearance on 2019-11-18, under approval number K191980.

What company makes CLEARFIL MAJESTY ES Flow?

CLEARFIL MAJESTY ES Flow is manufactured by Kuraray Noritake Dental, Inc..

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

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

Other Devices by Kuraray Noritake Dental, Inc.

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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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