FDA 510(k)

visio.lign 颜色，visio.lign 盾

K 號：K240735 · 2024-12-12

決定日期2024-12-12

產品代碼EBD

諮詢委員會DE

決定相當於

器材摘要

visio.lign color, visio.lign shield is the device name listed in this FDA 510(k) record. The listed applicant is Bredent GmbH & Co. KG. It received FDA 510(k) clearance on 2024-12-12 under 510(k) number K240735. The device is classified under product code EBD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the visio.lign color, visio.lign shield?

visio.lign color, visio.lign shield is a medical device that received FDA 510(k) clearance on 2024-12-12. The listed applicant is Bredent GmbH & Co. KG. The 510(k) number is K240735.

When did visio.lign color, visio.lign shield receive FDA 510(k) clearance?

visio.lign color, visio.lign shield received FDA 510(k) clearance on 2024-12-12, under 510(k) number K240735.

Who is the listed applicant for visio.lign color, visio.lign shield?

The FDA 510(k) record lists Bredent GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for visio.lign color, visio.lign shield?

The FDA product code for visio.lign color, visio.lign shield is EBD.

其他以 Bredent GmbH & Co. KG 為申請人之記錄

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相關器械（代碼：EBD）

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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