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FDA 510(k)

Apoller Flow Light Cure Flowable Composite

K-Number: K180463 · 2018-11-14

ApplicantGreenway Yw, LLC
Decision Date2018-11-14
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Apoller Flow Light Cure Flowable Composite is the device name listed in this FDA 510(k) record. The listed applicant is Greenway Yw, LLC. It received FDA 510(k) clearance on 2018-11-14 under 510(k) number K180463. 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 Apoller Flow Light Cure Flowable Composite?

Apoller Flow Light Cure Flowable Composite is a medical device that received FDA 510(k) clearance on 2018-11-14. The listed applicant is Greenway Yw, LLC. The 510(k) number is K180463.

When did Apoller Flow Light Cure Flowable Composite receive FDA 510(k) clearance?

Apoller Flow Light Cure Flowable Composite received FDA 510(k) clearance on 2018-11-14, under 510(k) number K180463.

Who is the listed applicant for Apoller Flow Light Cure Flowable Composite?

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

What is the FDA product code for Apoller Flow Light Cure Flowable Composite?

The FDA product code for Apoller Flow Light Cure Flowable Composite is EBF.

Related Clinical Trials

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.

NCT07504393Clinical Performance of Four Restorative Materials in Primary MolarsNOT_YET_RECRUITING

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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