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FDA 510(k)

ZIRDENT CAD/CAM BLOCKS

K-Number: K081253 · 2008-05-15

ApplicantC5 Medical Werks, Inc.
Decision Date2008-05-15
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZIRDENT CAD/CAM BLOCKS is the device name listed in this FDA 510(k) record. The listed applicant is C5 Medical Werks, Inc.. It received FDA 510(k) clearance on 2008-05-15 under 510(k) number K081253. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZIRDENT CAD/CAM BLOCKS?

ZIRDENT CAD/CAM BLOCKS is a medical device that received FDA 510(k) clearance on 2008-05-15. The listed applicant is C5 Medical Werks, Inc.. The 510(k) number is K081253.

When did ZIRDENT CAD/CAM BLOCKS receive FDA 510(k) clearance?

ZIRDENT CAD/CAM BLOCKS received FDA 510(k) clearance on 2008-05-15, under 510(k) number K081253.

Who is the listed applicant for ZIRDENT CAD/CAM BLOCKS?

The FDA 510(k) record lists C5 Medical Werks, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZIRDENT CAD/CAM BLOCKS?

The FDA product code for ZIRDENT CAD/CAM BLOCKS is EIH.

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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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