FDA 510(k)

CharmFil 注意：根據政策「medical-regulatory-v1」，公司/產品名稱、FDA、510(k)、PMA、NCT、PMID、識別符和網址應保持不變。由於原文中未提供相關識別符和網址，故此處未進行翻譯。

K 號：K193496 · 2020-05-06

決定日期2020-05-06

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

CharmFil is the device name listed in this FDA 510(k) record. The listed applicant is Dentkist, Inc.. It received FDA 510(k) clearance on 2020-05-06 under 510(k) number K193496. 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 CharmFil?

CharmFil is a medical device that received FDA 510(k) clearance on 2020-05-06. The listed applicant is Dentkist, Inc.. The 510(k) number is K193496.

When did CharmFil receive FDA 510(k) clearance?

CharmFil received FDA 510(k) clearance on 2020-05-06, under 510(k) number K193496.

Who is the listed applicant for CharmFil?

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

What is the FDA product code for CharmFil?

The FDA product code for CharmFil is EBF.

其他以 Dentkist, Inc. 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。

K152766CharmFlex

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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