FDA 510(k)

Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite

K-Number: K201010 · 2020-08-14

Decision Date2020-08-14

Product CodeEBF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Infinix Universal Composite, Infinix Flowable Composite, Infinix 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 2020-08-14 under 510(k) number K201010. 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 Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite?

Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite is a medical device that received FDA 510(k) clearance on 2020-08-14. The listed applicant is Nobio , Ltd.. The 510(k) number is K201010.

When did Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite receive FDA 510(k) clearance?

Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite received FDA 510(k) clearance on 2020-08-14, under 510(k) number K201010.

Who is the listed applicant for Infinix Universal Composite, Infinix Flowable Composite, Infinix 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 Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite?

The FDA product code for Infinix Universal Composite, Infinix Flowable Composite, Infinix 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.

NCT07212660A Clinical Trial to Compare the Safety and Performance of Two Different Curing Modes in the Direct Filling Therapy in Deciduous TeethRECRUITING NCT07547904Clinical Performance of Bioactive Bulk-Fill in Class II RestorationsRECRUITING NCT07504393Clinical Performance of Four Restorative Materials in Primary MolarsNOT_YET_RECRUITING NCT07524842Clinical Performance of Three Different Restorative MaterialsNOT_YET_RECRUITING NCT07612462Evaluation of the Clinical Performance of a Bulk Fill Resin Composite in Cuspal Coverage Restorations of Vital Posterior Teeth (RCT)ACTIVE_NOT_RECRUITING NCT07720999Effect of Different Heating Protocols of Resin Composites on Pulp Condition (Randomized Controlled Trial)COMPLETED

Other records listing Nobio , Ltd. as applicant

K183391Novidia Universal Bond K182921Infinix Universal Composite K182714Novidia Bulk Fill Flow Composite K182580Novidia Flowable Composite

Related Devices (Code: EBF)

K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K261246SRGC-06GC America, Inc.K261093DIAFILDiaDent Group International K261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)DiaDent Group International K260805Dual 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.