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FDA 510(k)

Zirconia Dental Ceramics

K-Number: K214005 · 2022-02-18

Decision Date2022-02-18
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Zirconia Dental Ceramics is a medical device manufactured by Shenzhen Yurucheng Dental Materials Co., Ltd.. It received FDA 510(k) clearance on 2022-02-18 under approval number K214005. 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 Dental Ceramics?

Zirconia Dental Ceramics is a medical device that received FDA 510(k) clearance on 2022-02-18. It is manufactured by Shenzhen Yurucheng Dental Materials Co., Ltd.. The 510(k) number is K214005.

When was Zirconia Dental Ceramics approved by the FDA?

Zirconia Dental Ceramics received FDA 510(k) clearance on 2022-02-18, under approval number K214005.

What company makes Zirconia Dental Ceramics?

Zirconia Dental Ceramics is manufactured by Shenzhen Yurucheng Dental Materials Co., Ltd..

What is the FDA product code for Zirconia Dental Ceramics?

The FDA product code for Zirconia Dental Ceramics is EIH.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.