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FDA 510(k)

PREMISE FLOWABLE MODIFIED

K-Number: K093484 · 2010-01-27

ApplicantKerr Corporation
Decision Date2010-01-27
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PREMISE FLOWABLE MODIFIED is the device name listed in this FDA 510(k) record. The listed applicant is Kerr Corporation. It received FDA 510(k) clearance on 2010-01-27 under 510(k) number K093484. 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 PREMISE FLOWABLE MODIFIED?

PREMISE FLOWABLE MODIFIED is a medical device that received FDA 510(k) clearance on 2010-01-27. The listed applicant is Kerr Corporation. The 510(k) number is K093484.

When did PREMISE FLOWABLE MODIFIED receive FDA 510(k) clearance?

PREMISE FLOWABLE MODIFIED received FDA 510(k) clearance on 2010-01-27, under 510(k) number K093484.

Who is the listed applicant for PREMISE FLOWABLE MODIFIED?

The FDA 510(k) record lists Kerr Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PREMISE FLOWABLE MODIFIED?

The FDA product code for PREMISE FLOWABLE MODIFIED 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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