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FDA 510(k)

Kingcera Dental Zirconia Blank

K-Number: K241602 · 2024-08-30

ApplicantHunan Qinghao Puzhong Technology Co., Ltd.
Decision Date2024-08-30
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Kingcera Dental Zirconia Blank is the device name listed in this FDA 510(k) record. The listed applicant is Hunan Qinghao Puzhong Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-08-30 under 510(k) number K241602. 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 Kingcera Dental Zirconia Blank?

Kingcera Dental Zirconia Blank is a medical device that received FDA 510(k) clearance on 2024-08-30. The listed applicant is Hunan Qinghao Puzhong Technology Co., Ltd.. The 510(k) number is K241602.

When did Kingcera Dental Zirconia Blank receive FDA 510(k) clearance?

Kingcera Dental Zirconia Blank received FDA 510(k) clearance on 2024-08-30, under 510(k) number K241602.

Who is the listed applicant for Kingcera Dental Zirconia Blank?

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

What is the FDA product code for Kingcera Dental Zirconia Blank?

The FDA product code for Kingcera Dental Zirconia Blank is EIH.

Other records listing Hunan Qinghao Puzhong Technology Co., Ltd. as applicant

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.

K261046Dental Zirconia Blank & Coloring Liquid

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 DandyK260918Zolid LunarisAmann Girrbach AGK260859Rosetta 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.

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