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FDA 510(k)

Zirconia Block

K-Number: K222520 · 2022-11-14

ApplicantYilink (Tianjin) Biotechnology Co., Ltd.
Decision Date2022-11-14
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Zirconia Block is a medical device manufactured by Yilink (Tianjin) Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2022-11-14 under approval number K222520. 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 Zirconia Block?

Zirconia Block is a medical device that received FDA 510(k) clearance on 2022-11-14. It is manufactured by Yilink (Tianjin) Biotechnology Co., Ltd.. The 510(k) number is K222520.

When was Zirconia Block approved by the FDA?

Zirconia Block received FDA 510(k) clearance on 2022-11-14, under approval number K222520.

What company makes Zirconia Block?

Zirconia Block is manufactured by Yilink (Tianjin) Biotechnology Co., Ltd..

What is the FDA product code for Zirconia Block?

The FDA product code for Zirconia Block is EIH.

Other Devices by Yilink (Tianjin) Biotechnology Co., Ltd.

K222513Glass Ceramics K242400Dental porcelain powder

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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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