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FDA 510(k)

DENU Composite Resin, DENU Flow Resin

K-Number: K213339 · 2022-09-23

ApplicantHdi, Inc.
Decision Date2022-09-23
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENU Composite Resin, DENU Flow Resin is a medical device manufactured by Hdi, Inc.. It received FDA 510(k) clearance on 2022-09-23 under approval number K213339. 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 DENU Composite Resin, DENU Flow Resin?

DENU Composite Resin, DENU Flow Resin is a medical device that received FDA 510(k) clearance on 2022-09-23. It is manufactured by Hdi, Inc.. The 510(k) number is K213339.

When was DENU Composite Resin, DENU Flow Resin approved by the FDA?

DENU Composite Resin, DENU Flow Resin received FDA 510(k) clearance on 2022-09-23, under approval number K213339.

What company makes DENU Composite Resin, DENU Flow Resin?

DENU Composite Resin, DENU Flow Resin is manufactured by Hdi, Inc..

What is the FDA product code for DENU Composite Resin, DENU Flow Resin?

The FDA product code for DENU Composite Resin, DENU Flow Resin is EBF.

Related Clinical Trials

NCT07612462 Evaluation of the Clinical Performance of a Bulk Fill Resin Composite in Cuspal Coverage Restorations of Vital Posterior Teeth (RCT) ACTIVE_NOT_RECRUITING NCT07524842 Clinical Performance of Three Different Restorative Materials NOT_YET_RECRUITING NCT07535086 Clinical Performance of Short Fiber Reinforced Flowable Versus Conventional Injectable Flowable Resin Composite Restorations in Class I Carious Cavities ACTIVE_NOT_RECRUITING NCT07504393 Clinical Performance of Four Restorative Materials in Primary Molars NOT_YET_RECRUITING

Other Devices by Hdi, Inc.

K222741DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)

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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