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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 the device name listed in this FDA 510(k) record. The listed applicant is Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2016-11-16 under 510(k) 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. The listed applicant is Prismatik Dentalcraft, Inc.. The 510(k) number is K162537.

When did CAD/CAMouflage Milling Block receive FDA 510(k) clearance?

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

Who is the listed applicant for CAD/CAMouflage Milling Block?

The FDA 510(k) record lists Prismatik Dentalcraft, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Related Devices (Code: EBF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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