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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 the device name listed in this FDA 510(k) record. The listed applicant is Nobio , Ltd.. It received FDA 510(k) clearance on 2019-07-03 under 510(k) 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. The listed applicant is Nobio , Ltd.. The 510(k) number is K182580.

When did Novidia Flowable Composite receive FDA 510(k) clearance?

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

Who is the listed applicant for Novidia Flowable Composite?

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

What is the FDA product code for Novidia Flowable Composite?

The FDA product code for Novidia Flowable Composite is EBF.

Other records listing Nobio , Ltd. 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.

K201010Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow CompositeK183391Novidia Universal BondK182921Infinix Universal CompositeK182714Novidia Bulk Fill Flow Composite

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

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

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