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FDA 510(k)

CLEARFIL MAJESTY FLOW

K-Number: K121583 · 2012-07-25

ApplicantKuraray Noritake Dental, Inc.
Decision Date2012-07-25
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CLEARFIL MAJESTY 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 2012-07-25 under 510(k) number K121583. 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 FLOW?

CLEARFIL MAJESTY FLOW is a medical device that received FDA 510(k) clearance on 2012-07-25. The listed applicant is Kuraray Noritake Dental, Inc.. The 510(k) number is K121583.

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

CLEARFIL MAJESTY FLOW received FDA 510(k) clearance on 2012-07-25, under 510(k) number K121583.

Who is the listed applicant for CLEARFIL MAJESTY 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 FLOW?

The FDA product code for CLEARFIL MAJESTY 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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, Inc.

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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