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FDA 510(k)

C-30皇冠套件

K 號：K211345 · 2021-11-24

申請人Perfect Fit Crowns, LLC
決定日期2021-11-24
產品代碼EBF
諮詢委員會DE
決定相當於

器材摘要

C-30 Crown Kit is the device name listed in this FDA 510(k) record. The listed applicant is Perfect Fit Crowns, LLC. It received FDA 510(k) clearance on 2021-11-24 under 510(k) number K211345. 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 C-30 Crown Kit?

C-30 Crown Kit is a medical device that received FDA 510(k) clearance on 2021-11-24. The listed applicant is Perfect Fit Crowns, LLC. The 510(k) number is K211345.

When did C-30 Crown Kit receive FDA 510(k) clearance?

C-30 Crown Kit received FDA 510(k) clearance on 2021-11-24, under 510(k) number K211345.

Who is the listed applicant for C-30 Crown Kit?

The FDA 510(k) record lists Perfect Fit Crowns, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C-30 Crown Kit?

The FDA product code for C-30 Crown Kit is EBF.

相關臨床試驗

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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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