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FDA 510(k)

HyperFil-LV

K-Number: K182296 · 2018-12-14

ApplicantParkell, Inc.
Decision Date2018-12-14
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HyperFil-LV is the device name listed in this FDA 510(k) record. The listed applicant is Parkell, Inc.. It received FDA 510(k) clearance on 2018-12-14 under 510(k) number K182296. 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 HyperFil-LV?

HyperFil-LV is a medical device that received FDA 510(k) clearance on 2018-12-14. The listed applicant is Parkell, Inc.. The 510(k) number is K182296.

When did HyperFil-LV receive FDA 510(k) clearance?

HyperFil-LV received FDA 510(k) clearance on 2018-12-14, under 510(k) number K182296.

Who is the listed applicant for HyperFil-LV?

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

What is the FDA product code for HyperFil-LV?

The FDA product code for HyperFil-LV is EBF.

Other records listing Parkell, Inc. as applicant

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.

K243254Parkell Pit and Fissure SealantK210259Parkell Self-Adhesive CementK191103Parkell Desensitizer GelK190930SmarTemp X1K172176Parkell Universal Adhesive

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.

K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K261246SRGC-06GC America, Inc.K261093DIAFILDiaDent Group InternationalK261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)DiaDent Group InternationalK260805Dual CoreVericom Co., Ltd.

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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