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FDA 510(k)

P1145 Dental Restorative

K-Number: K162257 · 2016-11-07

ApplicantKerr Corporation
Decision Date2016-11-07
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

P1145 Dental Restorative is a medical device manufactured by Kerr Corporation. It received FDA 510(k) clearance on 2016-11-07 under approval number K162257. 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 P1145 Dental Restorative?

P1145 Dental Restorative is a medical device that received FDA 510(k) clearance on 2016-11-07. It is manufactured by Kerr Corporation. The 510(k) number is K162257.

When was P1145 Dental Restorative approved by the FDA?

P1145 Dental Restorative received FDA 510(k) clearance on 2016-11-07, under approval number K162257.

What company makes P1145 Dental Restorative?

P1145 Dental Restorative is manufactured by Kerr Corporation.

What is the FDA product code for P1145 Dental Restorative?

The FDA product code for P1145 Dental Restorative is EBF.

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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) K151399Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq FlowSchutz Dental GmbH K162107TPH Spectra+ Universal Composite RestorativeDentsply Sirona 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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