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FDA 510(k)

Novidia Bulk Fill Flow Composite

K-Number: K182714 · 2019-07-12

ApplicantNobio , Ltd.
Decision Date2019-07-12
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Novidia Bulk Fill Flow 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 2019-07-12 under 510(k) 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. The listed applicant is Nobio , Ltd.. The 510(k) number is K182714.

When did Novidia Bulk Fill Flow Composite receive FDA 510(k) clearance?

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

Who is the listed applicant for Novidia Bulk Fill Flow 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 Bulk Fill Flow Composite?

The FDA product code for Novidia Bulk Fill Flow 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.

NCT07547904Clinical Performance of Bioactive Bulk-Fill in Class II RestorationsRECRUITINGNCT07212660A Clinical Trial to Compare the Safety and Performance of Two Different Curing Modes in the Direct Filling Therapy in Deciduous TeethRECRUITINGNCT07504393Clinical Performance of Four Restorative Materials in Primary MolarsNOT_YET_RECRUITINGNCT07524842Clinical Performance of Three Different Restorative MaterialsNOT_YET_RECRUITINGNCT07612462Evaluation of the Clinical Performance of a Bulk Fill Resin Composite in Cuspal Coverage Restorations of Vital Posterior Teeth (RCT)ACTIVE_NOT_RECRUITINGNCT07720999Effect of Different Heating Protocols of Resin Composites on Pulp Condition (Randomized Controlled Trial)COMPLETED

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 CompositeK182580Novidia Flowable 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

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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