FDA 510(k)

Ivotion 基礎列印機

K 號：K233995 · 2024-02-23

決定日期2024-02-23

產品代碼EBI

諮詢委員會DE

決定相當於

器材摘要

Ivotion Base Print is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, Inc.. It received FDA 510(k) clearance on 2024-02-23 under 510(k) number K233995. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ivotion Base Print?

Ivotion Base Print is a medical device that received FDA 510(k) clearance on 2024-02-23. The listed applicant is Ivoclar Vivadent, Inc.. The 510(k) number is K233995.

When did Ivotion Base Print receive FDA 510(k) clearance?

Ivotion Base Print received FDA 510(k) clearance on 2024-02-23, under 510(k) number K233995.

Who is the listed applicant for Ivotion Base Print?

The FDA 510(k) record lists Ivoclar Vivadent, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ivotion Base Print?

The FDA product code for Ivotion Base Print is EBI.

其他以 Ivoclar Vivadent, Inc. 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。

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相關器械（代碼：EBI）

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。

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官方來源

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