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FDA 510(k)

Topzir牙科氧化鋁空白板 & 牙科氧化鋁預著色空白板

K 號：K230003 · 2023-03-31

申請人Topzir Biotech Co., Ltd.
決定日期2023-03-31
產品代碼EIH
諮詢委員會DE
決定相當於

器材摘要

Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is the device name listed in this FDA 510(k) record. The listed applicant is Topzir Biotech Co., Ltd.. It received FDA 510(k) clearance on 2023-03-31 under 510(k) number K230003. 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 Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?

Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is a medical device that received FDA 510(k) clearance on 2023-03-31. The listed applicant is Topzir Biotech Co., Ltd.. The 510(k) number is K230003.

When did Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank receive FDA 510(k) clearance?

Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank received FDA 510(k) clearance on 2023-03-31, under 510(k) number K230003.

Who is the listed applicant for Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?

The FDA 510(k) record lists Topzir Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?

The FDA product code for Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is EIH.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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 DandyK260918佐立隆尼士Amann Girrbach AGK260859羅塞塔SM，羅塞塔SPHass Corp.

官方來源

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