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FDA 510(k)

Novidia Flowable Composite

K-Number: K182580 · 2019-07-03

ApplicantNobio , Ltd.
Decision Date2019-07-03
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Novidia Flowable Composite is a medical device manufactured by Nobio , Ltd.. It received FDA 510(k) clearance on 2019-07-03 under approval number K182580. 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 Novidia Flowable Composite?

Novidia Flowable Composite is a medical device that received FDA 510(k) clearance on 2019-07-03. It is manufactured by Nobio , Ltd.. The 510(k) number is K182580.

When was Novidia Flowable Composite approved by the FDA?

Novidia Flowable Composite received FDA 510(k) clearance on 2019-07-03, under approval number K182580.

What company makes Novidia Flowable Composite?

Novidia Flowable Composite is manufactured by Nobio , Ltd..

What is the FDA product code for Novidia Flowable Composite?

The FDA product code for Novidia Flowable Composite is EBF.

Related Clinical Trials

NCT07535086 Clinical Performance of Short Fiber Reinforced Flowable Versus Conventional Injectable Flowable Resin Composite Restorations in Class I Carious Cavities ACTIVE_NOT_RECRUITING

Other Devices by Nobio , Ltd.

K183391Novidia Universal Bond K182921Infinix Universal Composite K182714Novidia Bulk Fill Flow Composite K201010Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite

Related Devices (Code: EBF)

K163207Filtek One Bulk Fill Restorative3M Company K162537CAD/CAMouflage Milling BlockPrismatik Dentalcraft, Inc. K160049CharismaHeraeus Kulzer, LLC (Mitsui Chemicals Group) K162257P1145 Dental RestorativeKerr Corporation K151399Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq FlowSchutz Dental GmbH K162107TPH Spectra+ Universal Composite RestorativeDentsply Sirona

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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