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FDA 510(k)

Zirconia Block

K-Number: K233125 · 2024-01-12

Decision Date2024-01-12
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Zirconia Block is a medical device manufactured by Hangzhou Ivista Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2024-01-12 under approval number K233125. 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 2024-01-12. It is manufactured by Hangzhou Ivista Medical Devices Co., Ltd.. The 510(k) number is K233125.

When was Zirconia Block approved by the FDA?

Zirconia Block received FDA 510(k) clearance on 2024-01-12, under approval number K233125.

What company makes Zirconia Block?

Zirconia Block is manufactured by Hangzhou Ivista Medical Devices Co., Ltd..

What is the FDA product code for Zirconia Block?

The FDA product code for Zirconia Block is EIH.

Related Devices (Code: EIH)

Official Source

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