FDA 510(k)

輝煌不敗光輝

K 號：K152927 · 2016-04-28

決定日期2016-04-28

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

BRILLIANT EVERGLOW is the device name listed in this FDA 510(k) record. The listed applicant is Coltene/Whaledent AG. It received FDA 510(k) clearance on 2016-04-28 under 510(k) number K152927. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BRILLIANT EVERGLOW?

BRILLIANT EVERGLOW is a medical device that received FDA 510(k) clearance on 2016-04-28. The listed applicant is Coltene/Whaledent AG. The 510(k) number is K152927.

When did BRILLIANT EVERGLOW receive FDA 510(k) clearance?

BRILLIANT EVERGLOW received FDA 510(k) clearance on 2016-04-28, under 510(k) number K152927.

Who is the listed applicant for BRILLIANT EVERGLOW?

The FDA 510(k) record lists Coltene/Whaledent AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BRILLIANT EVERGLOW?

The FDA product code for BRILLIANT EVERGLOW is EBF.

其他以 Coltene/Whaledent AG 為申請人之記錄

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相關器械（代碼：EBF）

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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