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FDA 510(k)

Zirconia Block

K-Number: K241316 · 2024-07-09

ApplicantHunan Hualian Special Ceramics Co., Ltd.
Decision Date2024-07-09
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Zirconia Block is a medical device manufactured by Hunan Hualian Special Ceramics Co., Ltd.. It received FDA 510(k) clearance on 2024-07-09 under approval number K241316. 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 2024-07-09. It is manufactured by Hunan Hualian Special Ceramics Co., Ltd.. The 510(k) number is K241316.

When was Zirconia Block approved by the FDA?

Zirconia Block received FDA 510(k) clearance on 2024-07-09, under approval number K241316.

What company makes Zirconia Block?

Zirconia Block is manufactured by Hunan Hualian Special Ceramics Co., Ltd..

What is the FDA product code for Zirconia Block?

The FDA product code for Zirconia Block is EIH.

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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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