FDA 510(k)

DD立方ONE ML

K 號：K183569 · 2019-02-14

決定日期2019-02-14

產品代碼EIH

諮詢委員會DE

決定相當於

器材摘要

DD cube ONE ML is the device name listed in this FDA 510(k) record. The listed applicant is Dental Direkt GmbH. It received FDA 510(k) clearance on 2019-02-14 under 510(k) number K183569. 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 DD cube ONE ML?

DD cube ONE ML is a medical device that received FDA 510(k) clearance on 2019-02-14. The listed applicant is Dental Direkt GmbH. The 510(k) number is K183569.

When did DD cube ONE ML receive FDA 510(k) clearance?

DD cube ONE ML received FDA 510(k) clearance on 2019-02-14, under 510(k) number K183569.

Who is the listed applicant for DD cube ONE ML?

The FDA 510(k) record lists Dental Direkt GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DD cube ONE ML?

The FDA product code for DD cube ONE ML is EIH.

其他以 Dental Direkt GmbH 為申請人之記錄

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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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