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FDA 510(k)

CAD/CAMouflage Milling Bock

K-Number: K160425 · 2016-07-15

ApplicantPrismatik Dentalcraft, Inc.
Decision Date2016-07-15
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CAD/CAMouflage Milling Bock is a medical device manufactured by Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2016-07-15 under approval number K160425. 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 Bock?

CAD/CAMouflage Milling Bock is a medical device that received FDA 510(k) clearance on 2016-07-15. It is manufactured by Prismatik Dentalcraft, Inc.. The 510(k) number is K160425.

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

CAD/CAMouflage Milling Bock received FDA 510(k) clearance on 2016-07-15, under approval number K160425.

What company makes CAD/CAMouflage Milling Bock?

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

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

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

Other Devices by Prismatik Dentalcraft, Inc.

K162537CAD/CAMouflage Milling Block K160979Inclusive Abutments K153099INCLUSIVE TAPERED IMPLANT SYSTEM K170044Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System K191903BruxZir GT (Gum Tissue) Color K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV

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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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