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FDA 510(k)

CAD/CAMouflage Milling Block

K-Number: K162537 · 2016-11-16

ApplicantPrismatik Dentalcraft, Inc.
Decision Date2016-11-16
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CAD/CAMouflage Milling Block is a medical device manufactured by Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2016-11-16 under approval number K162537. 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 CAD/CAMouflage Milling Block?

CAD/CAMouflage Milling Block is a medical device that received FDA 510(k) clearance on 2016-11-16. It is manufactured by Prismatik Dentalcraft, Inc.. The 510(k) number is K162537.

When was CAD/CAMouflage Milling Block approved by the FDA?

CAD/CAMouflage Milling Block received FDA 510(k) clearance on 2016-11-16, under approval number K162537.

What company makes CAD/CAMouflage Milling Block?

CAD/CAMouflage Milling Block is manufactured by Prismatik Dentalcraft, Inc..

What is the FDA product code for CAD/CAMouflage Milling Block?

The FDA product code for CAD/CAMouflage Milling Block is EBF.

Other Devices by Prismatik Dentalcraft, Inc.

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Related Devices (Code: EBF)

K163207Filtek One Bulk Fill Restorative3M Company 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 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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