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FDA 510(k)

Apoller Flow Light Cure Flowable Composite

K-Number: K180463 · 2018-11-14

Decision Date2018-11-14
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Apoller Flow Light Cure Flowable Composite is a medical device manufactured by Greenway Yw, LLC. It received FDA 510(k) clearance on 2018-11-14 under approval 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. It is manufactured by Greenway Yw, LLC. The 510(k) number is K180463.

When was Apoller Flow Light Cure Flowable Composite approved by the FDA?

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

What company makes Apoller Flow Light Cure Flowable Composite?

Apoller Flow Light Cure Flowable Composite is manufactured by Greenway Yw, LLC.

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 Devices (Code: EBF)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.