FDA 510(k)

HIT 清晰正畸器

K 號：K210613 · 2021-06-04

決定日期2021-06-04

產品代碼NXC

諮詢委員會DE

決定相當於

器材摘要

HIT Clear Aligner is the device name listed in this FDA 510(k) record. The listed applicant is Cdb Corporation. It received FDA 510(k) clearance on 2021-06-04 under 510(k) number K210613. 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 HIT Clear Aligner?

HIT Clear Aligner is a medical device that received FDA 510(k) clearance on 2021-06-04. The listed applicant is Cdb Corporation. The 510(k) number is K210613.

When did HIT Clear Aligner receive FDA 510(k) clearance?

HIT Clear Aligner received FDA 510(k) clearance on 2021-06-04, under 510(k) number K210613.

Who is the listed applicant for HIT Clear Aligner?

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

What is the FDA product code for HIT Clear Aligner?

The FDA product code for HIT Clear Aligner is NXC.

其他以 Cdb Corporation 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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