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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 the device name listed in this FDA 510(k) record. The listed applicant is Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2021-07-02 under 510(k) 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. The listed applicant is Osstem Implant Co., Ltd.. The 510(k) number is K210097.

When did Estar-Z receive FDA 510(k) clearance?

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

Who is the listed applicant for Estar-Z?

The FDA 510(k) record lists Osstem Implant Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Estar-Z?

The FDA product code for Estar-Z is EIH.

Other records listing Osstem Implant Co., Ltd. as applicant

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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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