FDA 510(k)

Novidia Bulk Fill Flow Composite

K-Number: K182714 · 2019-07-12

Decision Date2019-07-12

Product CodeEBF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Novidia Bulk Fill Flow Composite is a medical device manufactured by Nobio , Ltd.. It received FDA 510(k) clearance on 2019-07-12 under approval number K182714. 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 Bulk Fill Flow Composite?

Novidia Bulk Fill Flow Composite is a medical device that received FDA 510(k) clearance on 2019-07-12. It is manufactured by Nobio , Ltd.. The 510(k) number is K182714.

When was Novidia Bulk Fill Flow Composite approved by the FDA?

Novidia Bulk Fill Flow Composite received FDA 510(k) clearance on 2019-07-12, under approval number K182714.

What company makes Novidia Bulk Fill Flow Composite?

Novidia Bulk Fill Flow Composite is manufactured by Nobio , Ltd..

What is the FDA product code for Novidia Bulk Fill Flow Composite?

The FDA product code for Novidia Bulk Fill Flow Composite is EBF.

Other Devices by Nobio , Ltd.

K183391Novidia Universal Bond K182921Infinix Universal Composite K182580Novidia Flowable 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

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