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FDA 510(k)

CLEARFIL MAJESTY POSTERIOR PLT

K-Number: K092281 · 2009-10-27

ApplicantKuraray Medical, Inc.
Decision Date2009-10-27
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CLEARFIL MAJESTY POSTERIOR PLT is the device name listed in this FDA 510(k) record. The listed applicant is Kuraray Medical, Inc.. It received FDA 510(k) clearance on 2009-10-27 under 510(k) number K092281. 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 POSTERIOR PLT?

CLEARFIL MAJESTY POSTERIOR PLT is a medical device that received FDA 510(k) clearance on 2009-10-27. The listed applicant is Kuraray Medical, Inc.. The 510(k) number is K092281.

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

CLEARFIL MAJESTY POSTERIOR PLT received FDA 510(k) clearance on 2009-10-27, under 510(k) number K092281.

Who is the listed applicant for CLEARFIL MAJESTY POSTERIOR PLT?

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

What is the FDA product code for CLEARFIL MAJESTY POSTERIOR PLT?

The FDA product code for CLEARFIL MAJESTY POSTERIOR PLT is EBF.

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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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