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FDA 510(k)

新世紀全瓷牙齒氧化鎂塊（未著色與預著色）

K 號：K172761 · 2017-11-17

申請人Shanghai New Century Dental Materials Co., Ltd.
決定日期2017-11-17
產品代碼EIH
諮詢委員會DE
決定相當於

器材摘要

New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai New Century Dental Materials Co., Ltd.. It received FDA 510(k) clearance on 2017-11-17 under 510(k) number K172761. 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 New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded)?

New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) is a medical device that received FDA 510(k) clearance on 2017-11-17. The listed applicant is Shanghai New Century Dental Materials Co., Ltd.. The 510(k) number is K172761.

When did New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) receive FDA 510(k) clearance?

New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) received FDA 510(k) clearance on 2017-11-17, under 510(k) number K172761.

Who is the listed applicant for New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded)?

The FDA 510(k) record lists Shanghai New Century Dental Materials Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded)?

The FDA product code for New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) 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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