FDA 510(k)

CREOKORREKT 調節器

K 號：K211427 · 2022-10-13

決定日期2022-10-13

產品代碼NXC

諮詢委員會DE

決定相當於

器材摘要

CREOKORREKT Aligners is the device name listed in this FDA 510(k) record. The listed applicant is Creodent Prosthetics, Ltd.. It received FDA 510(k) clearance on 2022-10-13 under 510(k) number K211427. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CREOKORREKT Aligners?

CREOKORREKT Aligners is a medical device that received FDA 510(k) clearance on 2022-10-13. The listed applicant is Creodent Prosthetics, Ltd.. The 510(k) number is K211427.

When did CREOKORREKT Aligners receive FDA 510(k) clearance?

CREOKORREKT Aligners received FDA 510(k) clearance on 2022-10-13, under 510(k) number K211427.

Who is the listed applicant for CREOKORREKT Aligners?

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

What is the FDA product code for CREOKORREKT Aligners?

The FDA product code for CREOKORREKT Aligners is NXC.

其他以 Creodent Prosthetics, Ltd. 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。

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相關器械（代碼：NXC）

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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