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FDA 510(k)

TPH Spectra+ Universal Composite Restorative

K-Number: K162107 · 2016-09-27

ApplicantDentsply Sirona
Decision Date2016-09-27
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TPH Spectra+ Universal Composite Restorative is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2016-09-27 under approval number K162107. 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+ Universal Composite Restorative?

TPH Spectra+ Universal Composite Restorative is a medical device that received FDA 510(k) clearance on 2016-09-27. It is manufactured by Dentsply Sirona. The 510(k) number is K162107.

When was TPH Spectra+ Universal Composite Restorative approved by the FDA?

TPH Spectra+ Universal Composite Restorative received FDA 510(k) clearance on 2016-09-27, under approval number K162107.

What company makes TPH Spectra+ Universal Composite Restorative?

TPH Spectra+ Universal Composite Restorative is manufactured by Dentsply Sirona.

What is the FDA product code for TPH Spectra+ Universal Composite Restorative?

The FDA product code for TPH Spectra+ Universal Composite Restorative is EBF.

Related Clinical Trials

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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 K153476KATANA AVENCIA BlockKuraray Noritake Dental, Inc.

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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