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FDA 510(k)

Estar-Z

K-Number: K210097 · 2021-07-02

ApplicantOsstem Implant Co., Ltd.
Decision Date2021-07-02
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Estar-Z is a medical device manufactured by Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2021-07-02 under approval number K210097. 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 Estar-Z?

Estar-Z is a medical device that received FDA 510(k) clearance on 2021-07-02. It is manufactured by Osstem Implant Co., Ltd.. The 510(k) number is K210097.

When was Estar-Z approved by the FDA?

Estar-Z received FDA 510(k) clearance on 2021-07-02, under approval number K210097.

What company makes Estar-Z?

Estar-Z is manufactured by Osstem Implant Co., Ltd..

What is the FDA product code for Estar-Z?

The FDA product code for Estar-Z is EIH.

Other Devices by Osstem Implant Co., Ltd.

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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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