FDA 510(k)

金采牙醫氧化鋁礦空白

K 號：K241602 · 2024-08-30

申請人Hunan Qinghao Puzhong Technology Co., Ltd.

決定日期2024-08-30

產品代碼EIH

諮詢委員會DE

決定相當於

器材摘要

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.

常見問題

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?

FDA 510(k) 記錄將湖南淸華普中科技有限公司列為申請人。這並不單獨確立設備製造商。

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

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

其他以 Hunan Qinghao Puzhong Technology Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261046牙醫用氧化鋁陶瓷空白片及上色液

相關器械（代碼：EIH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K262074任何-錫科斯Mediclus Co., Ltd.K262239Obsidian® 压克力壓克力超過鎂鋁Prismatik Dentalcraft, Inc.K261046牙醫用氧化鋁陶瓷空白片及上色液Hunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy陶瓷染色及釉料Zima International Inc., dba Dandy K260918佐立隆尼士Amann Girrbach AG K260859羅塞塔SM，羅塞塔SPHass Corp.

官方來源

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