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 the device name listed in this FDA 510(k) record. The listed applicant is Hunan Hualian Special Ceramics Co., Ltd.. It received FDA 510(k) clearance on 2024-07-09 under 510(k) 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. The listed applicant is Hunan Hualian Special Ceramics Co., Ltd.. The 510(k) number is K241316.

When did Zirconia Block receive FDA 510(k) clearance?

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

Who is the listed applicant for Zirconia Block?

The FDA 510(k) record lists Hunan Hualian Special Ceramics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zirconia Block?

The FDA product code for Zirconia Block is EIH.

Related Devices (Code: EIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc.K261046Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy Ceramic Stain and GlazeZima International Inc., dba Dandy K260918Zolid LunarisAmann Girrbach AG K260859Rosetta SM, Rosetta SPHass Corp.K253191DCMhotbond zirconDental Creativ Management GmbH

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.