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FDA 510(k)

Estar-ZE

K-Number: K242521 · 2024-11-20

ApplicantOsstem Implant Co., Ltd.
Decision Date2024-11-20
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Estar-ZE is a medical device manufactured by Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2024-11-20 under approval number K242521. 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-ZE?

Estar-ZE is a medical device that received FDA 510(k) clearance on 2024-11-20. It is manufactured by Osstem Implant Co., Ltd.. The 510(k) number is K242521.

When was Estar-ZE approved by the FDA?

Estar-ZE received FDA 510(k) clearance on 2024-11-20, under approval number K242521.

What company makes Estar-ZE?

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

What is the FDA product code for Estar-ZE?

The FDA product code for Estar-ZE 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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