FDA 510(k)

星 E900 手柄系列

K 號：K240183 · 2024-09-19

決定日期2024-09-19

產品代碼EGS

諮詢委員會DE

決定相當於

器材摘要

Star E900 Handpiece Series is the device name listed in this FDA 510(k) record. The listed applicant is Dentalez, Inc., Stardental Division. It received FDA 510(k) clearance on 2024-09-19 under 510(k) number K240183. The device is classified under product code EGS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Star E900 Handpiece Series?

Star E900 Handpiece Series is a medical device that received FDA 510(k) clearance on 2024-09-19. The listed applicant is Dentalez, Inc., Stardental Division. The 510(k) number is K240183.

When did Star E900 Handpiece Series receive FDA 510(k) clearance?

Star E900 Handpiece Series received FDA 510(k) clearance on 2024-09-19, under 510(k) number K240183.

Who is the listed applicant for Star E900 Handpiece Series?

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

What is the FDA product code for Star E900 Handpiece Series?

The FDA product code for Star E900 Handpiece Series is EGS.

其他以 Dentalez, Inc., Stardental Division 為申請人之記錄

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K251701星 E900 電動系統

相關器械（代碼：EGS）

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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