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FDA 510(k)

Zircos-Com

K-Number: K190139 · 2020-04-24

ApplicantBioden Co., Ltd.
Decision Date2020-04-24
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Zircos-Com is a medical device manufactured by Bioden Co., Ltd.. It received FDA 510(k) clearance on 2020-04-24 under approval number K190139. 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 Zircos-Com?

Zircos-Com is a medical device that received FDA 510(k) clearance on 2020-04-24. It is manufactured by Bioden Co., Ltd.. The 510(k) number is K190139.

When was Zircos-Com approved by the FDA?

Zircos-Com received FDA 510(k) clearance on 2020-04-24, under approval number K190139.

What company makes Zircos-Com?

Zircos-Com is manufactured by Bioden Co., Ltd..

What is the FDA product code for Zircos-Com?

The FDA product code for Zircos-Com is EBF.

Other Devices by Bioden Co., Ltd.

K201492Non-Sterile Zirconia Block

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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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