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FDA 510(k)

CLEARFIL MAJETY POSTERIOR

K-Number: K100328 · 2010-03-05

ApplicantKuraray Medical, Inc.
Decision Date2010-03-05
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CLEARFIL MAJETY POSTERIOR 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 2010-03-05 under 510(k) number K100328. 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 MAJETY POSTERIOR?

CLEARFIL MAJETY POSTERIOR is a medical device that received FDA 510(k) clearance on 2010-03-05. The listed applicant is Kuraray Medical, Inc.. The 510(k) number is K100328.

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

CLEARFIL MAJETY POSTERIOR received FDA 510(k) clearance on 2010-03-05, under 510(k) number K100328.

Who is the listed applicant for CLEARFIL MAJETY POSTERIOR?

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 MAJETY POSTERIOR?

The FDA product code for CLEARFIL MAJETY POSTERIOR 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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