FDA 510(k)

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K 號：K243370 · 2025-05-05

決定日期2025-05-05

產品代碼EBG

諮詢委員會DE

決定相當於

器材摘要

DentaTOOTH 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 2025-05-05 under 510(k) number K243370. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DentaTOOTH?

DentaTOOTH is a medical device that received FDA 510(k) clearance on 2025-05-05. The listed applicant is Asiga Pty, Ltd.. The 510(k) number is K243370.

When did DentaTOOTH receive FDA 510(k) clearance?

DentaTOOTH received FDA 510(k) clearance on 2025-05-05, under 510(k) number K243370.

Who is the listed applicant for DentaTOOTH?

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 DentaTOOTH?

The FDA product code for DentaTOOTH is EBG.

其他以 Asiga Pty, Ltd. 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。

K243356Asiga DentaBASE

相關器械（代碼：EBG）

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。

K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT 基座”及“FLNT 溫度”Liaoning Upcera Co., Ltd.K251271TempFIT 暫時冠橋膠Rizhao Huge Biomaterials Company, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E Exportação K243951TEMP MASTER，基於PMMA的牙科树脂Taiwan Dental Materials Co., Ltd.K242559數位體溫計Sprintray, Inc.

官方來源

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