FDA 510(k)

BASE290 LED 紫外線固化燈

K 號：K233518 · 2023-11-02

決定日期2023-11-02

產品代碼EBZ

諮詢委員會DE

決定相當於

器材摘要

BASE290 LED Curing Light is the device name listed in this FDA 510(k) record. The listed applicant is Handpiece Headquarters. It received FDA 510(k) clearance on 2023-11-02 under 510(k) number K233518. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BASE290 LED Curing Light?

BASE290 LED Curing Light is a medical device that received FDA 510(k) clearance on 2023-11-02. The listed applicant is Handpiece Headquarters. The 510(k) number is K233518.

When did BASE290 LED Curing Light receive FDA 510(k) clearance?

BASE290 LED Curing Light received FDA 510(k) clearance on 2023-11-02, under 510(k) number K233518.

Who is the listed applicant for BASE290 LED Curing Light?

The FDA 510(k) record lists Handpiece Headquarters as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BASE290 LED Curing Light?

The FDA product code for BASE290 LED Curing Light is EBZ.

其他以 Handpiece Headquarters 為申請人之記錄

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K243911HPR無線衛生手柄

相關器械（代碼：EBZ）

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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