FDA 510(k)

Asiga DentaBASE

K 號：K243356 · 2025-04-11

決定日期2025-04-11

產品代碼EBI

諮詢委員會DE

決定相當於

器材摘要

Asiga DentaBASE is the device name listed in this FDA 510(k) record. The listed applicant is Asiga Pty, Ltd.. It received FDA 510(k) clearance on 2025-04-11 under 510(k) number K243356. 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 Asiga DentaBASE?

Asiga DentaBASE is a medical device that received FDA 510(k) clearance on 2025-04-11. The listed applicant is Asiga Pty, Ltd.. The 510(k) number is K243356.

When did Asiga DentaBASE receive FDA 510(k) clearance?

Asiga DentaBASE received FDA 510(k) clearance on 2025-04-11, under 510(k) number K243356.

Who is the listed applicant for Asiga DentaBASE?

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

What is the FDA product code for Asiga DentaBASE?

The FDA product code for Asiga DentaBASE is EBI.

其他以 Asiga Pty, Ltd. 為申請人之記錄

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K243370牙齒牙齒

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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