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FDA 510(k)

TPH Spectra ST Flowable Composite Restorative

K-Number: K182288 · 2018-11-20

ApplicantDentsply Sirona
Decision Date2018-11-20
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TPH Spectra ST Flowable Composite Restorative is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2018-11-20 under approval number K182288. 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 TPH Spectra ST Flowable Composite Restorative?

TPH Spectra ST Flowable Composite Restorative is a medical device that received FDA 510(k) clearance on 2018-11-20. It is manufactured by Dentsply Sirona. The 510(k) number is K182288.

When was TPH Spectra ST Flowable Composite Restorative approved by the FDA?

TPH Spectra ST Flowable Composite Restorative received FDA 510(k) clearance on 2018-11-20, under approval number K182288.

What company makes TPH Spectra ST Flowable Composite Restorative?

TPH Spectra ST Flowable Composite Restorative is manufactured by Dentsply Sirona.

What is the FDA product code for TPH Spectra ST Flowable Composite Restorative?

The FDA product code for TPH Spectra ST Flowable Composite Restorative is EBF.

Related Clinical Trials

NCT07524842 Clinical Performance of Three Different Restorative Materials NOT_YET_RECRUITING NCT07547904 Clinical Performance of Bioactive Bulk-Fill in Class II Restorations 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

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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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